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Overview and Recommendations
Background
- •Tuberculosis (TB), caused by the Mycobacterium tuberculosis complex, is the leading infectious cause of death globally, with an estimated 10 million new cases and 1.5 million deaths annually. Despite being curable, TB remains a major public health threat driven by airborne transmission, slow diagnosis, and rising drug resistance, multidrug-resistant TB (MDR-TB) now accounts for nearly 500,000 new cases yearly.
- •The disease spectrum ranges from asymptomatic latent infection (LTBI) to active pulmonary and extrapulmonary disease. Approximately one-quarter of the world's population harbors LTBI, with a 5-10% lifetime risk of progression, concentrated in the first 2 years after infection. Subclinical TB, bacteriologically confirmed without symptoms, accounts for ~50% of prevalent cases in community surveys and contributes to transmission despite the absence of cough.
- •Pulmonary TB constitutes 70-80% of cases, but extrapulmonary involvement (lymphatic, pleural, meningeal, miliary) is common, especially in co-infection and children. (TBM) carries a 50% risk of death or severe neurologic disability even with treatment. The hallmark of progressive TB is caseating granuloma formation; failure of granuloma containment leads to cavity formation, dissemination, and hemoptysis.
- •Risk factors include HIV (20- to 37-fold increased risk), diabetes mellitus (2- to 3-fold), undernutrition (BMI <18.5), smoking, alcohol use (>40 g/day), therapy, end-stage renal disease, and close contact with an infectious case. Social determinants, poverty, crowding, incarceration, amplify transmission. The of M. tuberculosis is associated with enhanced virulence and drug resistance.
- •A paradigm shift has occurred in TB treatment: drug-susceptible TB can be treated in 4 months with a
Evaluation
- •Suspect active TB in any patient with cough lasting ≥2 weeks, unexplained fever, night sweats, weight loss, or hemoptysis. However, over 50% of culture-positive individuals in community prevalence surveys report no persistent cough, and ~25% have no symptoms at all, maintain a high index of suspicion regardless of symptom profile, particularly in endemic areas or high-risk groups.
- •Ask about prior TB treatment (risk of drug resistance), exposure to known cases, travel from or residence in endemic regions, HIV status, diabetes, immunosuppressive medications (especially agents), alcohol/tobacco use, and history of incarceration or homelessness.
- •Examine for cervical lymphadenopathy (matted, painless, may fistulize), pulmonary crackles or signs of consolidation, pleural effusion, and in severe cases meningeal signs (neck stiffness, cranial nerve palsies) suggesting . Assess for hepatosplenomegaly in miliary disease and signs of adrenal insufficiency (hyponatremia, hypotension) in disseminated TB.
- •Order a posteroanterior chest radiograph as initial imaging. Classic findings are upper-lobe infiltrates with cavitation, but HIV-positive patients more often have lower-lobe, interstitial, or miliary patterns. Chest CT provides greater sensitivity for small nodules, lymphadenopathy, and pleural effusion, useful when radiograph is equivocal.
- •Collect two sputum specimens (one spot, one early-morning) for and mycobacterial culture. Xpert Ultra has 88% sensitivity overall (90% in HIV-positive, 63% in smear-negative cases) and simultaneously detects resistance with >95% sensitivity. Culture on liquid (MGIT) or solid media remains the gold standard for definitive diagnosis and comprehensive phenotypic drug susceptibility testing.
- •If sputum is unavailable or negative with high suspicion, obtain bronchoalveolar lavage (BAL), induced sputum, or gastric aspirate (especially in children). For extrapulmonary TB, test appropriate specimens: (for TBM, send Xpert Ultra, culture, and consider adenosine deaminase [ADA]; cut-off ~40 U/L supports diagnosis), pleural fluid, pericardial fluid, pus from lymph nodes, or tissue biopsy for histology (caseating granuloma) and molecular testing.
- •Perform expanded drug susceptibility testing when rifampicin resistance is detected or in high-risk patients. Use (tNGS) directly on sputum for rapid detection of resistance to first- and second-line drugs (isoniazid, fluoroquinolones, bedaquiline, linezolid) with >95% sensitivity and specificity. Whole-genome sequencing from cultured isolates provides the most comprehensive resistance profile.
- •Apply severity stratification at diagnosis: classify pulmonary TB as extensive (high Xpert semiquantitative bacterial burden + extensive radiographic disease [cavitation grade ≥2]) versus limited disease. The phenotype identifies patients eligible for shortened 4-month therapy, those with extensive disease account for over half of post-treatment relapses and require full 6-month regimens. Time-to-detection <9 days in liquid culture identifies patients at high risk of transmission (OR 2.56).
- •For , use the MRC stage (stage I: alert; II: confused; III: comatose) and validated prognostic models that incorporate age, neurological signs, CSF lymphocyte count, and HIV status. The model achieves AUC 0.77-0.78 and is available as a web-based nomogram for bedside risk estimation. High CSF neutrophil count and culture positivity at diagnosis predict subsequent IRIS (RR 9.3).
- •Consider alternative diagnoses: (require culture identification), fungal infections ( , , in endemic areas), lung cancer (especially cavitating squamous cell carcinoma), sarcoidosis (non-caseating granulomas), and necrotizing bacterial pneumonia. In HIV, also consider pneumonia and disseminated fungal disease.
- •Assess for complications at initial evaluation: hemoptysis, from bronchiectasis or (mortality up to 50% if massive); acute respiratory failure, from extensive pulmonary or miliary disease; and adrenal insufficiency, suspected with hyponatremia, hyperkalemia, hypotension (33% pooled prevalence in TB patients).
Management
- •Initiate standard therapy for drug-susceptible pulmonary TB immediately upon microbiologic confirmation: a 2-month intensive phase of 10 mg/kg (max 600 mg) daily, 5 mg/kg (max 300 mg) daily, 25 mg/kg (max 2 g) daily, and 15-20 mg/kg (max 1.6 g) daily, followed by a 4-month continuation phase of rifampicin and isoniazid daily. Administer with pyridoxine 25-50 mg daily to prevent isoniazid-induced peripheral neuropathy.
- •Offer a shortened 4-month regimen for eligible drug-susceptible TB patients with limited disease (low bacterial burden and non-cavitary or minimal cavitation): substitute 1200 mg daily for rifampicin and add 400 mg daily, with the same companion drugs for 2 months followed by rifapentine-moxifloxacin for 2 months. This regimen is noninferior to the 6-month standard (unfavorable 11.6% vs 9.6%) and is safe in HIV with CD4 ≥100 cells/μL on efavirenz-based ART. Exclude patients with extensive disease (high Xpert burden + cavitation/extensive infiltrates).
- •For rifampicin-resistant or multidrug-resistant TB (MDR-TB), initiate a 24-week all-oral BPaLM regimen: 400 mg daily for 2 weeks then 200 mg three times weekly, 200 mg daily, 600 mg daily, and 400 mg daily. This regimen is superior to standard care (11% vs 48% unfavorable outcomes; risk difference -37 percentage points). For fluoroquinolone-resistant strains (pre-XDR), use BPaL (omit moxifloxacin).
- •Alternative all-oral 9-month regimens for fluoroquinolone-susceptible MDR-TB include BCLLfxZ (bedaquiline 400 mg daily for 2 wk then 200 mg 3×/wk, 100 mg daily, linezolid 600 mg daily, 1000 mg daily, pyrazinamide 25 mg/kg daily), BLMZ (bedaquiline, linezolid, moxifloxacin, pyrazinamide), or BDLLfxZ (bedaquiline, 100 mg twice daily, linezolid, levofloxacin, pyrazinamide) based on the endTB trial, all noninferior to standard therapy.
- •Monitor linezolid toxicity closely: peripheral neuropathy occurs in up to 38% and myelosuppression in 2-22% at 600 mg daily. Perform weekly CBC for the first 2 months, then monthly. Measure linezolid trough concentration, aim for <2 μg/mL to reduce toxicity. If trough >2 μg/mL or toxicity develops, reduce linezolid to 300 mg daily after 9-13 weeks; this dose maintains efficacy while significantly reducing adverse events (neuropathy 8% vs 14%, P = .02).
- •Use directly observed therapy (DOT) or video-supported therapy for every dose to ensure adherence and prevent acquired drug resistance. Daily dosing throughout treatment is recommended, avoid intermittent (thrice-weekly) dosing, especially in HIV-associated TB, where it increases failure (adjusted RR 4.0) and relapse (adjusted RR 4.8).
- •In patients with co-infection, start antiretroviral therapy (ART) within 2-8 weeks of TB treatment (earlier if CD4 <50 cells/μL, but monitor for IRIS). Adjust to 50 mg twice daily when co-administered with rifampicin (rifampicin induces UGT1A1 and CYP3A4). 600 mg daily requires no adjustment; requires 400 mg twice daily. is not recommended with rifampicin. Immune reconstitution inflammatory syndrome (IRIS) occurs in ~16% of HIV/TB patients, typically within 4-8 weeks of ART initiation, treat with NSAIDs or corticosteroids if symptomatic.
- •For , administer adjunctive 0.4 mg/kg/day IV/PO (tapered over 6-8 weeks) in all patients regardless of HIV status, reduces mortality and neurologic sequelae. For severe disease, consider high-dose rifampicin (35 mg/kg IV or 30 mg/kg orally) for improved outcomes, but monitor for hepatotoxicity. Maintain standard isoniazid, pyrazinamide, and ethambutol doses. Monitor for hyponatremia ( is common) and raised intracranial pressure.
- •In children with nonsevere, smear-negative, drug-susceptible TB, treat with 4 months of standard therapy (2HRZE/2HR) as per the SHINE trial, noninferior to 6 months (unfavorable 3% vs 3%). Use pediatric fixed-dose combinations and weight-based dosing. For severe TB (miliary, meningitis, bone/joint), extend treatment to 6-12 months. For children exposed to MDR-TB, offer 6 months of levofloxacin preventive therapy (TB-CHAMP trial, 56% reduction in TB incidence).
- •What NOT to do: Do not continue a rifampicin-based regimen when rifampicin resistance is confirmed by molecular or phenotypic testing. Do not use monotherapy or add a single new drug to a failing regimen, functional monotherapy is the strongest driver of acquired resistance. Do not use intermittent dosing in the intensive phase for HIV-positive patients. Do not use non-dihydropyridine calcium channel blockers (diltiazem, verapamil) in TB patients with heart failure, they are contraindicated and worsen outcomes.
- •Refer to a TB specialist or infectious disease consultant for: MDR/XDR-TB, tuberculous meningitis, treatment failure (positive culture after 2 months), drug intolerance or hepatotoxicity, pregnancy, children <5 years, or when surgical intervention (e.g., for massive hemoptysis from Rasmussen aneurysm) is needed. For MDR-TB, consultation with a national TB reference laboratory for expanded DST is essential.
- •After treatment completion, monitor for post-TB lung disease: assess respiratory symptoms and perform spirometry at 3-6 months. Over 50% of survivors have chronic airflow obstruction, bronchiectasis, or impaired diffusing capacity, manage with bronchodilators, airway clearance, and smoking cessation. Screen for (1-year mortality 15%) if new cavitation or hemoptysis. Manage cardiovascular risk factors aggressively, TB survivors have a 21% higher risk of ischemic heart disease (aHR 1.21) and 48% higher risk of myocardial infarction.
Board Review — High Yield
- •Subclinical TB, Over 50% of culture-positive pulmonary TB cases in community surveys do not report persistent cough; maintain a high index of suspicion regardless of symptoms, 23% of cough-free individuals have positive sputum smears.
- •Xpert MTB/RIF Ultra, First-line diagnostic test with 88% sensitivity (63% in smear-negative); detects rifampicin resistance simultaneously; preferred over smear microscopy for initial diagnosis.
- •4-month regimen, Rifapentine-moxifloxacin-based regimen is noninferior to standard 6-month therapy for drug-susceptible TB in patients without extensive disease (RIFASHORT phenotype).
- •BPaLM for MDR-TB, 24-week all-oral regimen (bedaquiline, pretomanid, linezolid, moxifloxacin) achieved 11% unfavorable outcomes vs 48% with standard care in TB-PRACTECAL trial; use BPaL if fluoroquinolone-resistant.
- •Linezolid toxicity, Peripheral neuropathy (up to 38%) and myelosuppression (2-22%) are dose-limiting; reduce to 300 mg daily after 9-13 weeks if trough >2 μg/mL or toxicity occurs, maintains efficacy, reduces harm.
- •Rifampicin-dolutegravir interaction, Double dolutegravir to 50 mg twice daily when co-administered with rifampicin (rifampicin induces UGT1A1 and CYP3A4); efavirenz and raltegravir (400 mg BID) alternatives.
- •TBM dexamethasone, Adjunctive dexamethasone 0.4 mg/kg/day tapered over 6-8 weeks reduces mortality and neurologic sequelae in tuberculous meningitis; use in all patients regardless of HIV status.
- •SHINE trial, Children with nonsevere smear-negative drug-susceptible TB can be treated with 4 months instead of 6 months (unfavorable 3% vs 3%), reduces treatment burden in a vulnerable population.
- •Post-TB lung disease, Over 50% of survivors have chronic pulmonary impairment (airflow obstruction, bronchiectasis, impaired diffusing capacity); assess spirometry at treatment completion and monitor for chronic pulmonary aspergillosis.
- •Preventive therapy for MDR contacts, Levofloxacin 6 months reduces TB incidence among household contacts of MDR-TB patients (adults: IRR 0.55; children: HR 0.44), now recommended by WHO.
Deep Dive — Evidence Details
Definition, Classification and Causative Organisms
- ▸TB is principally caused by *Mycobacterium tuberculosis* and must be distinguished from NTM disease. [751] [756] [760]
- ▸Clinical classification is primarily anatomical: pulmonary, extrapulmonary, tuberculous meningitis, and multisite or disseminated disease. [746] [748] [751]
- ▸AFB-negative results do not exclude pulmonary TB; culture, molecular testing, and sequencing provide complementary evidence. [750] [754] [760]
- ▸Drug-resistant TB is classified by the resistance pattern of the Mtb isolate; the supplied references do not establish new MDR, pre-XDR, or XDR thresholds. [753] [763]
- ▸In trials, 2-month culture conversion and early TTP changes over 14–28 days are operational response classifications rather than disease definitions. [744] [747]
- ▸Granulomas alone are nonspecific and should not be treated as proof of TB. [745]
Definition
Tuberculosis (TB) is an infectious disease caused by organisms of the Mycobacterium tuberculosis complex, principally M. tuberculosis (Mtb). The organism is detected or supported by acid-fast bacillus (AFB) microscopy, culture, molecular assays, or sequencing, although the sensitivity of each method varies with specimen type and bacillary burden. [756] [760] TB should be distinguished from disease caused by nontuberculous mycobacteria (NTM), which may produce similar pulmonary or extrapulmonary presentations but require different interpretation and management. [751] [754]C
The term “tuberculosis” may describe infection or clinically manifest disease; the cited studies primarily address active disease, including pulmonary TB, extrapulmonary TB, TB meningitis, HIV-associated TB, and drug-resistant TB. [746]C [751] [753] [757] The available evidence does not establish a new biological definition of TB, but it supports increasingly precise organism-level and site-based classification through culture, targeted sequencing, molecular testing, and postmortem tissue diagnosis. [746]C [750] [760] [763]D
Clinical classification
TB is conventionally classified by the principal anatomical site involved:
- Pulmonary TB (PTB): Disease involving the lung parenchyma or respiratory tract. Contemporary diagnostic studies evaluate sputum, bronchoalveolar lavage fluid, bronchoscopic specimens, chest CT findings, AFB microscopy, culture, PCR, and sequencing in suspected PTB. [750] [754]C [760]
- Extrapulmonary TB (EPTB): Disease occurring outside the lungs. The cited multicentre Indian study recruited people with presumptive pulmonary and extrapulmonary TB, confirming that both presentations are encountered in routine diagnostic pathways. [751]
- Tuberculous meningitis (TBM): A severe extrapulmonary form involving the meninges and central nervous system. Its true burden is difficult to quantify because conventional cerebrospinal-fluid diagnostics are imperfect; minimally invasive tissue sampling has been investigated as an alternative postmortem approach to complete diagnostic autopsy. [746]C
- Disseminated or multisite TB: This term is appropriate when disease involves multiple noncontiguous anatomical sites, although the supplied studies do not provide a new formal diagnostic threshold. It should not be confused with disseminated NTM infection, which was reported in all patients in a multicentre tracheobronchial NTM series. [748]
TB may also be classified according to host context. HIV-associated TB is a clinically important category in which advanced HIV disease, CD4-cell count, viral load, antiretroviral regimen, and timing of antiretroviral therapy influence clinical management and outcomes. [757] Immunosuppression can delay recognition of pulmonary TB because constitutional symptoms, inflammatory markers, and radiographic abnormalities may be attributed to autoimmune disease or treatment-related effects. [758]C
Microbiological and resistance classification
A microbiological classification distinguishes bacteriologically confirmed TB from clinically diagnosed or bacteriologically negative disease. AFB-positive and AFB-negative pulmonary TB populations were separately evaluated in a Vietnamese diagnostic study, demonstrating that a negative smear does not define absence of TB. [760] Molecular testing can identify Mtb directly, while culture remains important for confirmation and susceptibility testing. Targeted sequencing and nanopore-based methods are being evaluated to improve speed and detection, particularly when conventional testing is slow or infrastructure is limited. [750] [756] [760] [763]D
Drug-resistant TB (DR-TB) is classified by the resistance pattern of the infecting Mtb isolate. The available evidence specifically addresses resistance to first- and second-line drugs, minimum inhibitory concentration distributions, and genomic or targeted next-generation sequencing approaches for detecting resistance. [753] [763]D The supplied references do not provide validated resistance thresholds for defining multidrug-resistant, pre-extensively drug-resistant, or extensively drug-resistant TB; such labels should therefore be applied only according to the current applicable standard rather than inferred from a single MIC or sequencing result. [753]
In clinical trials, treatment response may be classified using culture conversion or surrogate measures of bacillary burden. Time to culture conversion at approximately 2 months is used as a phase 2b endpoint, while early bactericidal activity studies commonly assess time-to-positivity (TTP) during the first 14 days and may extend observation to 28 days. [744] Non-culture measures such as the Tuberculosis Molecular Bacterial Load Assay (TB-MBLA), together with colony-forming units and TTP, are being evaluated as response biomarkers. [747]
Causative organisms and important mimics
The principal causative organism of TB is Mtb. NTM are separate mycobacterial species that can cause pulmonary, tracheobronchial, disseminated, or other disease and are frequently mistaken for TB in people with presumptive TB. [748] [751] NTM identification should therefore be based on species-level microbiology or validated molecular/genomic characterization when possible. A newly described example is Mycobacterium shunyiense, identified from human respiratory specimens using phenotypic, biochemical, chemotaxonomic, 16S rRNA, average nucleotide identity, and digital DNA–DNA hybridization analyses. [761]D
Detection of mycobacterial DNA alone should be interpreted in clinical context, because assays must distinguish Mtb from NTM. A 16S rRNA real-time PCR assay was evaluated against GeneXpert MTB/RIF in pulmonary TB and NTM controls, while bronchoscopic smear studies assessed incremental information from separate brushing specimens. [754]C [760] Coinfection with nonmycobacterial pathogens can also occur; an experimental lung-cell model specifically examined simultaneous Mtb and SARS-CoV-2 infection. [762]D Finally, granulomatous inflammation is not pathognomonic for TB: rare hepatic granulomas have been reported in ANCA-associated vasculitis, underscoring the need for microbiological or molecular confirmation when feasible. [745]C
| Category | Definition or distinguishing feature | Evidence |
|---|---|---|
| Pulmonary TB | Mtb disease involving the lungs or respiratory tract; evaluated with respiratory specimens and imaging | [750] [754]C [760] |
| Extrapulmonary TB | Mtb disease outside the lungs | [751] |
| Tuberculous meningitis | Extrapulmonary TB involving the meninges or CNS | [746]C |
| Drug-resistant TB | TB caused by an Mtb isolate with resistance to one or more relevant anti-TB drugs | [753] [763]D |
| NTM disease | Disease caused by mycobacteria other than Mtb; may mimic TB or disseminate | [748] [751] [761]D |
| Bacteriologically confirmed TB | Supported by AFB microscopy, culture, molecular detection, or sequencing | [750] [754]C [760] |
Microbiology and Pathogenesis
- ▸Mtb persistence depends on intracellular survival, inhibition of phagosomal maturation, immune evasion, and adaptation to macrophage and lesion heterogeneity. [768][770][776][778]
- ▸Macrophage glycolysis, TCA-cycle metabolites, amino-acid metabolism, polarization, and metal availability collectively influence containment versus persistence. [86][767][773]
- ▸Paucibacillary extrapulmonary TB may require combined imaging, histopathology, culture, and molecular testing because conventional microbiology can be insensitive. [159][160]
- ▸Respiratory-virus coinfection, pregnancy, HIV infection, and immunosuppression can alter TB immune protection and clinical outcomes. [764][771][777]
- ▸Gut microbiome, host biomarkers, non-coding RNA, computational pathway analysis, mucosal vaccination, and immunotherapy are promising but predominantly emerging or investigational areas. [509][765][766][769][772][775]
Microbiology
Tuberculosis (TB) is caused by Mycobacterium tuberculosis (Mtb), an obligate human pathogen that primarily infects the respiratory tract and resides intracellularly, particularly within alveolar macrophages. [762]D[776]D Rapid distinction between the M. tuberculosis complex (MTBC) and clinically important nontuberculous mycobacteria (NTM), including Mycobacterium avium complex and M. abscessus complex, is essential because conventional acid-fast bacillus (AFB) microscopy and culture do not reliably provide rapid species-level identification. [774]D A multicentre evaluation of 845 respiratory specimens assessed a multiplex real-time PCR assay for direct detection of MTBC, MAC, and MABSC against culture and AFB staining, illustrating the continuing need for molecular differentiation in suspected mycobacterial disease. [774]D
Mtb genetic diversity contributes to variable host–pathogen interactions. In single-cell experiments, bacterial lineage and macrophage phenotype jointly influenced phagosomal acidification, with distinct Mtb lineages producing different effects in M1- and M2-like macrophages. [770]D Thus, infection is not biologically uniform: outcomes may reflect the combination of bacterial genotype, macrophage heterogeneity, lesion microenvironment, and host immune state. [770]D[778]D
Host–pathogen interaction
TB pathogenesis reflects a prolonged, bidirectional interaction between protective host immunity and Mtb immune-evasion strategies. These interactions, together with immunometabolic and epigenetic reprogramming, shape granuloma formation and organization, fibrotic encapsulation, liquefactive necrosis, disease progression, and transmission. [768]D Mtb survives in macrophages partly by subverting phagosomal maturation and resisting acidic stress; it inhibits phagosome acidification, although experimental work indicates that enhancing early acidification alone does not necessarily predict reduced intracellular bacterial survival. [776]D Macrophage phenotype is therefore important but not determinative, and lesion-specific macrophage polarization may contribute to the coexistence of progressive and more contained pulmonary lesions within the same patient. [778]D
Infection induces complex metabolic rewiring involving glycolysis, the tricarboxylic acid (TCA) cycle, and amino-acid metabolism. [86]D5 A glycolytic, HIF-1α-associated, “Warburg-like” response and accumulation of immunomodulatory TCA intermediates can alter macrophage polarization and antimicrobial activity; M1/M2 balance may determine bacterial containment versus persistence. [773]D However, these metabolic changes can be exploited by Mtb both to suppress host antimicrobial functions and to obtain nutrients. [86]D5 Cytokine- and metabolite-mediated systemic effects may extend beyond the lung and contribute to skeletal-muscle dysregulation and TB-associated cachexia. [773]D
Nutritional immunity also shapes infection. Zinc is required by both host and pathogen, while sequestration of essential metals is an innate host strategy to restrict microbial growth. [767]D Calprotectin, a neutrophil-derived metal-chelating protein, participates in limiting microbial access to metal cofactors, although the precise contribution of zinc restriction to Mtb pathogenesis remains incompletely defined. [767]D
Immune determinants and vulnerable states
The balance between protective immunity and immunopathology determines whether infection remains controlled or progresses. Investigational immunotherapies are being developed as adjuncts to chemotherapy, particularly in the context of multidrug-resistant TB, prolonged treatment, and suboptimal adherence. [772]D Host immune responses are also altered by physiological or infectious comorbidity. Pregnancy and HIV infection are associated with increased vulnerability to TB because of altered immune protection, although important knowledge gaps remain regarding optimal prevention and treatment in pregnancy. [777]D In high-HIV/high-TB settings, including sub-Saharan Africa, respiratory-virus coinfection may substantially modify TB outcomes. [771]D
Mtb and respiratory viruses—including SARS-CoV-2, influenza, respiratory syncytial virus, parainfluenza, metapneumovirus, rhinovirus, adenovirus, and bocavirus—can interact across latent, subclinical, active, and reactivation stages of TB. [771]D Coinfection biology involves remodeling of innate-sensing and inflammatory pathways, including Toll-like receptor, RIG-I, and cGAS–STING-related responses. [771]D An experimental A549 lung-epithelial-cell model provides a standardized system for studying simultaneous Mtb and SARS-CoV-2 infection through sequential bacterial and viral culture, coinfection, intracellular bacterial-load measurement, and viral-viability testing. [762]D
Microbiological expression and extrapulmonary disease
TB may occur outside the lungs and can be paucibacillary, reducing the sensitivity of smear microscopy and conventional microbiology. [160]C4 In a nine-patient series of maxillofacial tuberculous osteomyelitis, nonspecific swelling, ulceration, or trismus frequently complicated recognition; imaging showed osteolysis, cortical breach, periosteal reaction, or soft-tissue abscess, while rapid molecular testing such as cartridge-based nucleic-acid amplification testing was emphasized because conventional testing often had low sensitivity. [160]C4 Ischial TB similarly presented with gluteal pain in 100.0% of 22 patients, sitting-induced pain in 81.8%, and local swelling in 59.1%; CT identified lesions in 86.4%, whereas MRI demonstrated abnormalities in all 18 examined patients. [159]C4 Histopathology, microbiology, and molecular testing were used together for confirmation, supporting a multimodal approach in anatomically difficult or paucibacillary disease. [159]C4[160]C4
Emerging molecular and systems perspectives
Host biomarkers and computational approaches are expanding mechanistic investigation. Plasma TIM-1, IFN-γ, and IL-17 were measured in cohorts with pulmonary TB, latent TB infection, and healthy controls to examine disease-stage expression, cytokine relationships, and predictive-model performance. [765] Long non-coding RNA HCP5 has also been investigated as a potential diagnostic and treatment-monitoring biomarker in ulcerative cutaneous TB, using bioinformatic networks, patient tissue, and BCG-infected macrophage experiments. [509]B3b Graph neural networks, transformer models, and multimodal learning have been applied to TB, antigen-processing, and NF-κB pathway networks to characterize nonlinear pathway–gene relationships, although such approaches remain mechanistic and exploratory rather than established clinical standards. [769]D
The gut–lung axis is another emerging determinant. TB has been associated with reduced gut-microbial diversity and enrichment of pro-inflammatory taxa, with microbiome composition linked to disease severity and treatment response. [766]D Sequencing, metabolomics, and artificial-intelligence methods may identify diagnostic or prognostic signatures, while probiotics and other microbiome-directed interventions remain investigational. [766]D Mucosal vaccine strategies seek to address the limited pulmonary protection provided by systemic BCG vaccination; in mice, a protein-only candidate containing ESAT6 and CFP10 with cholera-toxin-B and IgG-Fc components induced antigen-specific systemic and bronchoalveolar responses, including polyfunctional Th1 and Th17 responses. [775]D
| Theme | Evidence-supported implication |
|---|---|
| Intracellular survival | Mtb inhibits phagosome maturation and acidification in macrophages; early acidification enhancement does not alone guarantee bacterial clearance. [776]D |
| Macrophage heterogeneity | Mtb lineage and macrophage phenotype jointly influence phagosomal acidification and infection outcome. [770]D |
| Immunometabolism | Glycolysis, TCA-cycle intermediates, amino-acid metabolism, and M1/M2 polarization shape antimicrobial activity and persistence. [86]D5[773]D |
| Nutritional immunity | Calprotectin-mediated metal sequestration restricts access to zinc and other essential cofactors, although mechanisms remain incompletely resolved. [767]D |
| Extrapulmonary diagnosis | MRI, CT, histopathology, and molecular tests complement low-sensitivity conventional microbiology in ischial and maxillofacial TB. [159]C4[160]C4 |
| Emerging systems biology | Gut microbiome profiling, host biomarkers, lncRNA, and AI-based pathway analysis may support diagnosis, prognosis, or personalized management but require validation. [509]B3b[765][766]D[769]D |
Epidemiology, Transmission and Risk Factors
- ▸TB remains the leading infectious cause of death worldwide, with >10 million new cases and 1.5 million deaths annually.
- ▸Subclinical TB (no persistent cough) accounts for 59% of community-detected cases and contributes to transmission.
- ▸HIV, diabetes, undernutrition, smoking, alcohol, immunosuppressive therapy, and household TB contact are the major modifiable risk factors; HCWs have a 2.94-fold higher incidence of active TB.
- ▸Latent infection confers 79% protection against progressive disease upon re-exposure, reinforcing the importance of LTBI screening and treatment.
The airborne route of transmission explains why tuberculosis disproportionately affects populations in crowded, poorly ventilated settings, and why incidence varies dramatically across geographies. In 2019, an estimated 10 million people developed tuberculosis worldwide, and 1.5 million died, making it the leading infectious cause of death globally [212]D5[211]D5. Incidence is slowly declining overall, but drug-resistant cases are rising, particularly in Eastern Europe, Central Asia, and parts of Africa [214]D5[213]D5. In low-incidence settings like the United States, TB incidence has fallen to 7 per 100 000 in New York City (2001-2022), yet foreign-born individuals account for 57% of all US cases [239]B2c[253]B2b. Racial and ethnic disparities are stark: Native Hawaiian/Pacific Islander persons in Arkansas have a 173-fold higher risk than non-Hispanic Whites (risk ratio 173.6; 95%) [259]B2b.
Transmission dynamics
Mycobacterium tuberculosis is transmitted via airborne droplet nuclei generated by coughing, sneezing, or talking. Crucially, 59% of pulmonary TB cases in community surveys do not report persistent cough, and ∼25% of those without cough have positive sputum smears, confirming that subclinical disease contributes to transmission [15]B2c[205]C4. The risk of transmission is highest in households, congregate settings (prisons, shelters, long-term care facilities), and healthcare environments [188]D5[218]B2a. Health care workers have a 2.94-fold higher incidence of active TB compared with the general population (IRR 2.94; 95%) [218]B2a.
Host risk factors
Progression from latent infection to active disease occurs most rapidly in the first 2 years after infection, and is driven by a cluster of immunosuppressive and social determinants [211]D5. The major risk factors with quantified associations are summarised in the table below.
| Risk Factor | Effect Estimate (OR/RR/HR) | Evidence Level |
|---|---|---|
| Diabetes mellitus | OR 1.18 (95% CI 1.06-1.30) for LTBI [168]B2a | Meta-analysis |
| Undernutrition (BMI <18.5) | OR not reported, but consistently associated [257]B2b[211]D5 | Cohort studies |
| Smoking (active) | OR not reported, but dose-dependent risk [211]D5[237]B2b | Meta-analyses |
| Alcohol use (>40 g/day) | Attributable fraction 1.4% of all TB deaths (GBD 2016) [186]B2c | Systematic analysis |
| TNF inhibitor therapy | HR not reported for TB alone; tofacitinib HR 1.48 (95% CI 1.04-2.09) for cancers/MACE [177]A1b | RCT |
| Immunosuppressive therapy (any) | HR not reported, but strong risk for disseminated TB [257]B2b | Cohort |
| End-stage renal disease | Risk factor for disseminated TB [257]B2b | Cohort |
Special populations and temporal considerations
People with latent tuberculosis infection (LTBI) who are re-exposed have a 79% lower risk of progressive disease than naïve individuals (IRR 0.21; 95%), indicating partial protective immunity [169]B2a. Pregnancy does not independently increase TB infection risk, but all TB disease in screened pregnant women with LTBI occurred during pregnancy or the postpartum period [254]B2b. In incarcerated populations, TB incidence can be several-fold higher than in the community, driven by overcrowding and delayed diagnosis [222]C4[188]D5.
Seasonal variation is not well established for TB, unlike many respiratory viruses. The global burden of drug-resistant TB is concentrated in previously treated patients and is fuelled by inadequate treatment adherence and transmission of resistant strains [221]B2a[235]B3b.
Pearl: The single most actionable risk for progression is untreated LTBI: screen with IGRA or TST in high-risk groups (foreign-born, immunocompromised, HCWs, contacts) and treat with a short -based regimen, 1 month of + reduces TB incidence by an estimated 85% and is noninferior to 9 months of isoniazid alone [185]A1b[174]A1c.
| Risk Factor | Effect Estimate (OR/RR/HR) | Evidence Level |
|---|---|---|
| Diabetes mellitus | OR 1.18 (95% CI 1.06-1.30) [168]B2a | Meta-analysis |
| Undernutrition (BMI <18.5) | Strong association, not quantified [257]B2b[211]D5 | Cohort |
| Smoking (active) | Dose-dependent risk [211]D5[237]B2b | Meta-analysis |
| Alcohol (>40 g/day) | Attributable 1.4% of TB deaths [186]B2c | Systematic analysis |
| TNF inhibitor therapy | TB risk elevated [177]A1b | RCT |
| Immunosuppressive therapy | Risk factor for disseminated TB [257]B2b | Cohort |
| End-stage renal disease | Risk factor for disseminated TB [257]B2b | Cohort |
Clinical Presentation
- ▸TB may be asymptomatic, pulmonary, extrapulmonary, or disseminated; household contacts of drug-resistant TB patients require attention because prolonged exposure increases infection and progression risk. [779]
- ▸Pulmonary TB may cause low-grade fever, weight loss, nodules, consolidation, and mediastinal lymphadenopathy, but these findings can mimic autoimmune disease or malignancy. [750,758,790]
- ▸HIV infection and immunosuppression can produce atypical disease, extrapulmonary involvement, low organism burden, and difficulty obtaining sputum. [758,788]
- ▸Central nervous system and ocular TB may mimic other emergencies or malignancy, including metastatic brain disease and acute retinal necrosis. [786,792]
- ▸An initial tuberculin skin-test result of 0–4 mm in a patient with inborn errors of immunity may warrant repeat testing after 1–4 weeks. [783]
- ▸Isolated indirect hyperbilirubinaemia with normal transaminases should not automatically be attributed to anti-TB drug-induced liver injury. [759]
Tuberculosis (TB) has a highly variable clinical presentation, ranging from asymptomatic infection to severe, disseminated, or organ-specific disease. Household contacts of patients with drug-resistant TB have increased risks of acquiring infection and progressing to disease because of prolonged exposure; systematic contact screening is therefore clinically important even when contacts have no symptoms. Screening and preventive-treatment practices vary substantially between settings. [779]
Pulmonary tuberculosis
Pulmonary TB may present with constitutional and respiratory features, but the clinical picture can be subtle or nonspecific. Reported manifestations include recurrent low-grade fever, marked weight loss, pulmonary nodules, pulmonary consolidation, and mediastinal lymphadenopathy. These abnormalities may be mistaken for autoimmune disease activity, particularly in patients receiving immunosuppressive therapy. [758]C Patient delay is clinically relevant because delayed recognition is associated with increased mortality; a meta-analysis including 42 studies and 492,448 patients evaluated factors associated with delay in seeking care. [780]
Radiographic abnormalities are not uniform. Chest computed tomography (CT) may show nodules, consolidation, and lymphadenopathy, but these findings are not specific to TB and may resemble malignancy, inflammatory disease, or other infections. [750][758]C[790] In patients with suspected pulmonary TB, CT assessment combined with bronchoalveolar-lavage-fluid testing and nanopore targeted sequencing was investigated as a strategy to improve diagnostic yield; this is particularly relevant when conventional microbiological testing is inconclusive. [750]
Atypical disease in immunocompromised patients
People living with HIV may have atypical presentations, including a higher frequency of extrapulmonary disease, difficulty producing sputum, and low organism burden in clinical specimens. These factors can reduce the sensitivity of conventional tests and complicate diagnosis. [788] Urinary lipoarabinomannan testing has therefore been investigated in HIV-associated TB, where conventional testing may be limited by atypical manifestations, extrapulmonary involvement, inability to obtain sputum, and low bacterial loads. [788]
Immunosuppressive treatment can obscure the presentation of pulmonary TB. A patient initially considered to have Sjögren syndrome or undifferentiated connective-tissue disease developed recurrent low-grade fever, substantial weight loss, pulmonary nodules, consolidation, mediastinal lymphadenopathy, and painful subcutaneous nodules during sequential treatment with glucocorticoids, belimumab, tocilizumab, and baricitinib. [758]C This illustrates the need to reconsider TB when presumed autoimmune disease is accompanied by progressive constitutional or pulmonary findings during immunosuppression. [758]C
Patients with inborn errors of immunity require individualized assessment incorporating exposure history, symptoms, tuberculin skin testing, and chest imaging. In one cohort, an initial tuberculin skin-test result of 0–4 mm prompted repeat testing after 1–4 weeks, emphasizing that an initially nonreactive result may require reassessment in a high-risk host. [783]C In psoriasis, interferon-gamma release assay positivity was specifically studied before biologic therapy, reflecting the clinical importance of latent-TB assessment before immunomodulation. [782]
Extrapulmonary and disseminated tuberculosis
TB can involve the central nervous system, eye, liver, ear, and other sites. Tuberculous meningitis may cause sensorineural hearing loss; examination of infant temporal bones demonstrated cochlear fibrosis, organ-of-Corti atrophy, neuronal loss, and purulent inflammatory material in the internal auditory canal, with possible spread from the subarachnoid space through inner-ear structures. [787]C
Tuberculous brain abscess is an uncommon presentation that may mimic metastatic intracranial disease. An elderly, HIV-negative woman presented with subacute unilateral weakness and dysarthria, while imaging showed multiple rim-enhancing brain lesions. Biopsy revealed purulent material with abundant acid-fast bacilli; unusually, well-formed epithelioid granulomas were absent. [792]D
Ocular TB may mimic acute retinal necrosis. A reported elderly woman developed rapid visual loss, elevated intraocular pressure, mutton-fat keratic precipitates, severe anterior-chamber and vitreous inflammation, retinal arteritis, and peripheral retinal necrosis. Failure of antiviral therapy supported reconsideration of presumed viral retinitis and recognition of tuberculous uveitis. [786]C
Comorbidities and treatment-related clinical interpretation
Diabetes mellitus can modify host responses to M. tuberculosis. Hyperglycaemia was associated with altered macrophage phenotype and impaired phagocytic and intracellular antimicrobial responses in patients with TB and diabetes, potentially influencing disease behavior and clinical vulnerability. [789]
Clinical findings during treatment also require careful interpretation. Isolated indirect hyperbilirubinaemia with persistently normal transaminases is atypical for classical hepatocellular drug-induced liver injury and may reflect Gilbert syndrome rather than anti-TB drug toxicity. [759]C In drug-resistant TB, mortality and treatment outcomes may be poor; a retrospective Eritrean cohort evaluated clinical, haematological, and biochemical factors associated with mortality in 257 patients treated between 2013 and 2023. [784]
Diagnostic context
Symptoms and imaging alone cannot reliably distinguish TB from non-tuberculous mycobacterial infection, malignancy, autoimmune disease, or other opportunistic infections. In patients with AIDS, plasma extracellular-vesicle-associated microRNAs were investigated as potential biomarkers for distinguishing TB from non-tuberculous mycobacterial infection. [781]C Rapid molecular and sequencing approaches, including targeted next-generation sequencing for drug resistance, may assist diagnosis, although implementation can be limited by operational barriers identified among clinicians, laboratory staff, and policymakers. [763]D The time to culture conversion is also used in clinical trials as an objective marker of microbiological response, with 2-month culture conversion serving as a phase 2b endpoint. [744]
Diagnosis and Workup
- ▸Maintain suspicion for TB during immunosuppression when constitutional symptoms, pulmonary lesions, or lymphadenopathy could be misattributed to autoimmune disease. [758]
- ▸Household contacts of drug-resistant TB patients require systematic screening, but local strategies and preventive-treatment regimens vary substantially. [779]
- ▸In IEI patients, repeat an initially negative TST of **0–4 mm** after **1–4 weeks** when clinically indicated. [783]
- ▸Use microbiological testing and resistance assessment whenever possible; TBM specimens may be paucibacillary and have limited volume. [797]
- ▸mNGS, NTS, tNGS, multiplex PCR, tongue swabs, machine learning, and extracellular-vesicle microRNAs are emerging or adjunctive approaches, not universal replacements for established diagnostic pathways. [750] [763] [781] [796]
Initial clinical assessment
Evaluate tuberculosis (TB) in patients with compatible respiratory or systemic illness, epidemiologic exposure, or increased susceptibility, and document symptom history, exposure history, immune status, prior TB, and prior treatment. Diagnostic delay is particularly likely when pulmonary abnormalities, inflammatory markers, constitutional symptoms, or lymphadenopathy are attributed to autoimmune disease or immunosuppressive therapy rather than infection. [758]C Patients receiving immunosuppression may develop pulmonary nodules, consolidation, mediastinal lymphadenopathy, weight loss, fever, and extrapulmonary lesions, so TB should remain in the differential diagnosis even when connective-tissue disease is suspected. [758]C
Household contacts of patients with drug-resistant TB require systematic evaluation because prolonged household exposure increases the risk of infection and progression to disease. Screening strategies and tuberculosis preventive-treatment regimens vary substantially by country and setting; implementation barriers and evidence gaps should therefore be considered when interpreting local contact-management pathways. [779]
Testing for infection and disease
For latent TB infection (LTBI) assessment, interferon-gamma release assay (IGRA) is used before biologic therapy in patients with psoriasis, although positivity is influenced by clinical factors and should be interpreted in context. A 2026 single-center study evaluated 1,126 psoriasis patients without documented prior TB, including 285 IGRA-positive and 841 IGRA-negative patients, and developed an internally validated model of factors associated with IGRA positivity. [782] In adults with inborn errors of immunity, assessment included exposure history, symptom review, tuberculin skin testing (TST), and chest imaging; when the initial TST induration was 0–4 mm, testing was repeated after 1–4 weeks. [783]C
A positive infection test does not by itself establish active TB. Symptom assessment and chest imaging remain necessary, with radiography and computed tomography (CT) used in the IEI cohort according to availability and clinical assessment. [783]C CT can support pulmonary TB evaluation, but imaging findings overlap with nontuberculous mycobacterial (NTM) disease and other pulmonary infections. A retrospective study of 102 microbiologically confirmed cases—53 Mycobacterium tuberculosis lung disease and 49 NTM lung disease—developed an interpretable multimodal machine-learning model combining symptoms, hematologic markers, and high-resolution CT features to distinguish the two conditions. [794]
Microbiological confirmation
Obtain respiratory material whenever possible for acid-fast bacillus (AFB) smear microscopy, nucleic-acid testing, culture, and drug-resistance testing. In a bronchoscopy study of 43 adults, separate bronchial-brushing smears were compared with routinely processed bronchoscopic specimens to determine whether brushing provided incremental information; the evidence was retrospective and single-center. [754]C For patients unable to provide sputum or in settings where sputum collection is difficult, tongue swabs are being evaluated as a non-sputum specimen: in Ethiopian prisons, adult incarcerated men with cough of any duration provided two swabs, including an early-morning swab and a second swab 30 minutes later, for Xpert MTB/RIF Ultra processing. [798]D
Bronchoalveolar lavage fluid (BALF) can be tested by molecular methods. In a retrospective study of 380 patients, chest CT screening was combined with nanopore targeted sequencing (NTS) of BALF to improve pulmonary-TB diagnosis, and radiologists with different experience levels were compared for preliminary CT assessment. [750] Metagenomic next-generation sequencing (mNGS) may provide complementary pathogen detection in pulmonary infection: among 218 patients undergoing BALF testing, overall mNGS positivity was higher than culture positivity (95.4% vs 67.4%; P<0.001), while overall concordance was 71.1%. [796] These results support mNGS as an adjunct rather than a replacement for conventional testing, because concordance was incomplete and the study was retrospective. [796]
Multiplex molecular assays may simultaneously identify Mycobacterium tuberculosis complex, NTM, and resistance markers. In 300 characterized samples, an open real-time PCR assay detected M. tuberculosis complex with 100% sensitivity and 100% specificity; NTM sensitivity was 70.0% with 100% specificity. [799]D Targeted next-generation sequencing (tNGS) is also being considered for rapid direct detection of drug-resistant TB from sputum, but qualitative implementation research from Indonesia identified operational barriers and enablers rather than establishing diagnostic accuracy. [763]D
Drug resistance and paucibacillary disease
Resistance testing should be pursued promptly when drug-resistant TB is suspected, particularly in household contacts of drug-resistant cases and in patients with previous exposure to TB treatment. [779] Tuberculous meningitis (TBM) poses special diagnostic challenges because cerebrospinal-fluid specimens are typically paucibacillary and available in limited volumes. A laboratory-based study evaluated a testing cascade comprising cartridge-based nucleic-acid amplification testing, automated liquid culture, line-probe assays, and phenotypic drug-susceptibility testing to characterize resistance and diagnostic attrition. [797]
Special differentials and emerging biomarkers
Consider NTM infection, fungal disease, autoimmune disease, and other granulomatous disorders when microbiology is negative or findings are atypical. Hepatic granulomas are an exceedingly rare manifestation of ANCA-associated vasculitis and can create a difficult differential diagnosis with infectious granulomatous disease, including TB. [745]C In patients with AIDS, plasma extracellular-vesicle-associated microRNAs are being investigated to distinguish TB from NTM infection; the study used a small discovery set of 15 patients and a validation cohort of 110 patients, so this approach remains investigational. [781]C
Non-culture biomarkers such as time to positivity and TB molecular bacterial load assay (TB-MBLA) are being studied mainly for treatment-response monitoring rather than routine diagnosis. Pharmacometric machine-learning models used baseline and serial time-to-positivity data to predict 2-month culture conversion in clinical-trial participants, while joint modeling evaluated TB-MBLA, colony-forming units, and time-to-positivity in 78 patients from an early-bactericidal-activity trial. [744] [747] These biomarkers may accelerate research assessments but should not replace microbiological confirmation in clinical workup. [744] [747]
| Clinical question | Suggested approach | Evidence and limitations |
|---|---|---|
| Infection/LTBI screening | IGRA or TST with exposure and immune-status assessment; repeat TST after 1–4 weeks if initial induration is 0–4 mm in IEI | Psoriasis and IEI cohorts; population-specific evidence [782] [783]C |
| Pulmonary disease | Chest radiography/CT plus respiratory microbiology; consider BALF when needed | CT features overlap with NTM and other disease [750] [794] |
| Molecular detection | Xpert MTB/RIF Ultra, multiplex PCR, NTS, mNGS, or tNGS according to specimen and availability | Mostly retrospective or implementation evidence [750] [763]D [796] [798]D [799]D |
| Drug resistance | Molecular testing followed, where feasible, by culture-based and phenotypic susceptibility testing | Especially important in DR-TB exposure and TBM [779] [797] |
| Differential diagnosis | Evaluate NTM, autoimmune granulomatous disease, and other infections when findings are atypical | Supported by NTM-discrimination, vasculitis, and AIDS studies [745]C [781]C [794] |
Severity Assessment and Risk Stratification
- ▸Use multidimensional assessment: physiology, organ involvement, disease extent, host vulnerability, drug resistance, and treatment delay. [403][780][801]
- ▸Baseline CRP is an accessible mortality-associated biomarker, but no universal clinical cutoff is established in the cited evidence. [403]
- ▸Neurological deficit, paraplegia, instability, or cord compression in spinal TB constitutes high-risk disease. [804]
- ▸Suspected MDR, pre-XDR, or XDR TB increases concern for delayed diagnosis, prolonged therapy, morbidity, and poor outcomes. [808]
- ▸After treatment, assess for COPD and post-tuberculosis airway stenosis when respiratory symptoms persist. [237][809][811]
Scope and principles
Severity assessment in tuberculosis (TB) should be multidimensional rather than based on a single symptom, radiographic finding, or laboratory value. The available evidence supports integrating acute mortality risk, organ dysfunction, disease site and extent, antimicrobial resistance, host vulnerability, and the likelihood of delayed diagnosis or treatment. Most of the cited evidence is observational or systematic-review evidence of heterogeneous populations; therefore, prognostic markers should complement, not replace, bedside assessment and microbiological confirmation. [403]B2a[801]
Immediate clinical severity
At presentation, assess airway and breathing, oxygenation, respiratory distress, hemodynamic instability, altered mental status, nutritional status, and evidence of disseminated or extrapulmonary disease. Hospital-level evaluation is particularly appropriate when there is respiratory failure, severe systemic illness, suspected central nervous system involvement, spinal cord compression, extensive disease, or major immunosuppression. The cited mortality meta-analysis specifically evaluated adults ≥18 years with microbiologically confirmed TB and baseline C-reactive protein (CRP), indicating that prognostic interpretation should be anchored to the population and timing studied. [403]B2a
For spinal TB, neurological status is a major severity determinant. Thoracic spinal TB may cause vertebral destruction, instability, and neurological deficits; a retrospective surgical cohort of 148 patients evaluated clinical, laboratory, and imaging variables associated with paraplegia at presentation and developed a clinical-imaging severity stratification framework. [804] New or progressive weakness, sensory loss, sphincter dysfunction, severe deformity, or imaging evidence of cord compression should therefore be treated as high-risk features requiring urgent specialist assessment. [804]
Biomarker-based mortality risk
Baseline CRP is a practical, widely available inflammatory biomarker. A systematic review and meta-analysis assessed whether baseline CRP predicts mortality in adults with microbiologically confirmed TB, using adjusted hazard ratios and adjusted odds ratios as prognostic measures; study quality was assessed with the QUIPS tool and data extraction followed the CHARMS-PF checklist. [403]B2a CRP should be interpreted as a continuous risk marker and in clinical context rather than as a universal stand-alone cutoff, because the supplied evidence does not establish one threshold applicable across TB sites, HIV status, treatment settings, or assay platforms. [403]B2a
Other routinely available variables may add prognostic information, but their value is context-dependent. In hospitalized HIV-associated pulmonary TB, a hospital-based observational cohort of 107 HIV-positive adults evaluated tuberculin skin-test responsiveness as a potential surrogate when CD4 testing is unavailable, alongside nutritional status assessed by body-mass index. [810]C A nonreactive tuberculin test may reflect impaired cell-mediated immunity, but this study does not justify using tuberculin responsiveness as a replacement for CD4-cell measurement or comprehensive clinical assessment. [810]C
Host and disease modifiers
HIV infection, advanced immunosuppression, malnutrition, comorbid lung disease, and delayed presentation increase concern for severe disease or poor outcome. A meta-analysis of 42 studies involving 492,448 patients examined factors associated with patient delay, which is clinically important because delayed diagnosis and treatment can permit progression and may worsen outcomes; however, delay-associated factors should be used to trigger earlier evaluation rather than to assign an individual mortality probability. [780]
Drug resistance is a major risk-stratification domain. A systematic review of 20 studies comprising 1,242 patients with multidrug-resistant, pre-extensively drug-resistant, or extensively drug-resistant skeletal TB described delayed diagnosis, prolonged therapy, increased morbidity, and variable management strategies. [808] Suspected or confirmed resistance should prompt rapid molecular or phenotypic susceptibility assessment and specialist management, because resistance changes treatment complexity and prognosis. [808]
Host genetic variation may modify susceptibility and clinical manifestations: a systematic review identified 32 studies evaluating Toll-like receptor 2 polymorphisms in pulmonary TB. [409]B3a These findings are biologically relevant but are not currently a routine bedside severity score or a substitute for clinical and microbiological risk assessment. [409]B3a
Anatomical extent and complications
Extrapulmonary disease should be graded according to threatened organ function. Spinal TB with paraplegia or instability is high severity, while unusual osseous sites can still cause substantial functional morbidity. In a 22-patient series of ischial TB, gluteal pain occurred in all patients, sitting-induced pain in 81.8%, and local swelling in 59.1%; CT detected lesions in 86.4% and MRI abnormalities in all 18 patients examined. [159]C4 These findings support MRI when neurological, pelvic, or deep soft-tissue complications are suspected, but the small retrospective series cannot define mortality risk. [159]C4
Incorrect prior procedures can worsen local disease. In 53 patients with spinal TB who had undergone inappropriate vertebral augmentation, subsequent treatment strategies and prognostic outcomes were retrospectively compared, emphasizing the need to consider TB before vertebral augmentation in destructive spinal lesions. [802]C Post-treatment sequelae also matter: a population-based cohort of 25,896 pulmonary-TB patients identified post-tuberculosis airway stenosis in 265 patients, or 1%, with evaluation based on bronchoscopy, imaging, and symptoms. [811] Persistent dyspnea, stridor, wheeze, or reduced exercise tolerance after treatment warrants assessment for structural airway disease. [811]
Long-term risk after treatment
Severity assessment should continue beyond microbiological cure. A prospective cohort enrolled adults with newly diagnosed pulmonary TB who completed standard treatment and followed them through June 2025 to evaluate incident chronic obstructive pulmonary disease (COPD) using serial symptom and lung-function assessments. [237]B2b TB and post-TB lung disease are also clinically relevant in established COPD: a population-based retrospective cohort evaluated their association with exacerbations and mortality. [809] Patients with persistent respiratory symptoms, extensive residual radiographic disease, airway stenosis, or pre-existing COPD merit pulmonary-function testing and structured follow-up. [237]B2b[809]
Interpretation of emerging models
Advanced statistical and computational approaches—including Bayesian, machine-learning, spatiotemporal, time-series, multistate, and survival models—have been reviewed for TB diagnosis and treatment outcomes in Africa. [801] Such tools may improve population-level prediction, but external validation, calibration, interpretability, and local applicability are essential before clinical adoption. [801] Evidence from pediatric AIDS cohorts, talaromycosis studies, neutropenic oncology guidelines, pulmonary lymphangioleiomyomatosis case reports, peritoneal-dialysis peritonitis, and respiratory microbiome research should not be directly converted into TB severity thresholds because these studies address different diseases, populations, or outcomes. [400]A1c[800][803][806]C[807][410]B2b
Overall, classify TB as high risk when there is physiological instability, major organ dysfunction, neurological compromise, disseminated disease, severe immunosuppression or malnutrition, markedly elevated or rising inflammatory markers, suspected drug resistance, or substantial structural complications. These features warrant urgent escalation, while risk estimates should remain diagnosis-, site-, host-, and setting-specific. [403]B2a[804][808][810]C
| Domain | High-risk indicators or implications |
|---|---|
| Acute physiology | Respiratory distress or failure, hypoxemia, hemodynamic instability, altered mental status, or severe systemic illness. [403]B2a[801] |
| Inflammation and immunity | Elevated or rising baseline CRP; advanced HIV-related immune dysfunction; nonreactive tuberculin testing may indicate impaired cellular immunity but is not a substitute for CD4 testing. [403]B2a[810]C |
| Neurological and structural disease | Paraplegia, progressive neurological deficit, spinal instability, vertebral destruction, or cord compression. [804][802]C |
| Resistance | Suspected or confirmed MDR, pre-XDR, or XDR TB, particularly in skeletal disease. [808] |
| Extrapulmonary complications | Deep osseous or pelvic disease, threatened organ function, or disseminated involvement. [159]C4 |
| Post-treatment risk | Persistent dyspnea or exercise limitation suggesting COPD, post-TB lung disease, or airway stenosis; PTAS was identified in 1% of 25,896 pulmonary-TB patients in one cohort. [237]B2b[809][811] |
Empiric Management, Acute Care and Source Control
- ▸A negative T-SPOT.TB result should not be used alone to exclude bacteriologically confirmed pulmonary TB [819].
- ▸mNGS can complement conventional testing in difficult respiratory infection, but available evidence does not support replacing standard TB microbiology or susceptibility testing [817, 793].
- ▸Resistance-aware treatment requires local epidemiology, rapid susceptibility information, and specialist input; the supplied evidence does not establish a universal empiric regimen [814, 820, 821].
- ▸Worsening after at least **10 days** of therapy may represent a paradoxical CNS-TB reaction, but treatment failure and alternative diagnoses must first be reassessed [815].
- ▸Medication stock-outs, household transmission, immunosuppression, undernutrition, hepatic steatosis, and drug interactions can materially complicate acute TB care [813, 823, 758, 827, 822, 816].
Scope and evidence boundaries
The supplied evidence does not provide a complete empiric-treatment protocol for suspected tuberculosis (TB), and it should not be used to replace local or national TB guidelines, expert consultation, or drug-susceptibility testing. One included study concerns upadacitinib for non-segmental vitiligo rather than TB and therefore contributes no evidence for TB acute care, empiric therapy, or source control [812]. The remaining evidence is predominantly observational, retrospective, pharmacometric, diagnostic, or case-based; consequently, regimen selection, duration, corticosteroid use, isolation duration, and procedural source control cannot be specified from these references alone [744, 813-827].
Immediate assessment and diagnostic priorities
When active pulmonary TB is clinically suspected, acute evaluation should prioritize obtaining bacteriological specimens and drug-resistance information while assessing the patient’s severity, respiratory status, immune status, comorbidities, nutritional state, and potential extrapulmonary involvement. The evidence supports caution against using a negative T-SPOT.TB result to exclude active disease: in a cohort of 4,931 bacteriologically confirmed pulmonary-TB adults, false-negative results were specifically investigated, underscoring that interferon-γ release testing is an adjunct rather than a definitive rule-out test in active TB [819].
Bronchoalveolar-lavage metagenomic next-generation sequencing (mNGS) may complement conventional microbiology in diagnostically difficult lower-respiratory-tract infection. In a retrospective cohort of 754 patients, mNGS positivity was 84.5%, and mycobacteria accounted for 9.43% of detected pathogen categories; however, the study evaluated heterogeneous respiratory infections and does not establish that mNGS should replace smear, culture, nucleic-acid testing, or susceptibility testing for TB [817]. A separate fever-of-unknown-origin study evaluated the diagnostic contribution, pathogen spectrum, specimen type, and therapeutic impact of mNGS, but its retrospective design and heterogeneous population limit direct application to empiric TB decisions [793].
Empiric therapy and resistance-aware management
Treatment should be individualized according to the probability of TB, disease site and severity, prior treatment, exposure history, local resistance epidemiology, and rapid susceptibility results. The Korean prospective observational cohort specifically examined a 6-month fluoroquinolone-containing FqREZ regimen for isoniazid-mono-resistant pulmonary TB and compared it with alternative non-FqREZ therapy; the study was designed to assess treatment success without recurrence within 12 months after completion and serious adverse events, but the supplied abstract does not provide the outcome estimates needed to justify broader empiric use [814].
Drug-resistant TB requires early specialist and programmatic involvement because treatment is associated with second-line medicines, prolonged therapy, intensive monitoring, hospitalization, and substantially higher direct medical costs [820]. Resistance patterns may be geographically and institutionally variable: a five-year study of 9,389 hospitalized pulmonary-TB patients in Guizhou characterized temporal and epidemiological trends in drug resistance, but the supplied information does not provide a universal empiric regimen [821]. Rifampicin exposure may also select or enrich resistance determinants in co-resident organisms: among 165 Klebsiella pneumoniae isolates from a specialized infectious-disease hospital, whole-genome sequencing assessed the arr determinant and its association with documented rifampicin exposure [818]. This finding reinforces the need to interpret microbiological results carefully and to involve laboratory and antimicrobial-stewardship specialists.
Early bactericidal activity and culture conversion remain important endpoints in regimen development. A pharmacometrics-enabled machine-learning analysis used baseline and serial time-to-positivity data from phase 2a TB trials to predict 2-month culture conversion, comparing models and the effect of phase 2a sampling duration up to 14 or 28 days [744]. These results are investigational and do not support changing clinical treatment solely on the basis of predicted conversion.
Acute complications and paradoxical worsening
Clinical deterioration after treatment initiation does not automatically indicate microbiological failure. In a prospective cohort of 57 HIV-negative children aged 6 months to 14 years with CNS TB, paradoxical reactions were defined as new or worsening lesions or symptoms after initial improvement following at least 10 days of anti-TB therapy; clinical assessment, cerebrospinal-fluid analysis, and neuroimaging were performed at baseline, during worsening, or at 8 weeks, with functional outcome assessed at 6 months [815]C. Such deterioration requires urgent reassessment for treatment failure, resistance, nonadherence, alternative diagnoses, complications, and paradoxical inflammation; the supplied evidence does not define a corticosteroid regimen.
Extrapulmonary TB may mimic other emergencies. A case of presumed ocular TB presented as acute retinal necrosis with rapid visual loss, elevated intraocular pressure, severe intraocular inflammation, retinal arteritis, and peripheral necrotic lesions; antiviral therapy and corticosteroids failed to halt progression before TB-directed reconsideration [786]C. This supports urgent multidisciplinary ophthalmologic and infectious-disease assessment when ocular findings are atypical or refractory, without establishing a universal diagnostic or treatment pathway.
Source control, continuity, and host factors
Operational source control should include reliable treatment access, medication-supply monitoring, and appropriate evaluation of close contacts. A systematic review found that stock-outs of antiretroviral, anti-TB, and antimalarial medicines remain a major challenge in low- and middle-income countries and synthesized causes, consequences, and mitigation strategies [813]. In Southwest Ethiopia, adult household contacts of smear-positive pulmonary-TB patients were studied for bacteriologically confirmed disease, directly demonstrating the importance of contact-focused case finding in exposed households [823].
Immunosuppression can delay recognition and permit progressive disease. A case report described pulmonary TB initially attributed to connective-tissue disease activity during sequential treatment with glucocorticoids, belimumab, tocilizumab, and baricitinib, followed by fever, weight loss, pulmonary lesions, lymphadenopathy, and subcutaneous nodules [758]C. TB assessment should therefore remain active when infection-compatible deterioration occurs during immunosuppression. Nutritional and metabolic assessment is also relevant: undernutrition was examined among 362 Somali patients with TB [827], while a global comparative-risk analysis linked six suboptimal dietary exposures with TB mortality and disability-adjusted life years across 1990-2021 [824]. Hepatic steatosis was investigated as a factor associated with delayed sputum-smear conversion, defined as persistent positivity beyond 8 weeks after standard treatment [822].
In advanced HIV disease, drug-interaction planning is essential. A pharmacokinetic study of 15 adults receiving dolutegravir-based antiretroviral therapy during 1 month of daily rifapentine plus isoniazid preventive therapy, alongside fluconazole for cryptococcal meningitis, measured drug concentrations on days 1, 5, and 14 [816]. These preventive-therapy data should not be extrapolated automatically to active TB treatment; medication reconciliation and specialist review remain necessary.
| Clinical problem | Evidence-supported response | Limitation |
|---|---|---|
| Suspected pulmonary TB | Obtain bacteriological specimens and resistance information; do not rely on T-SPOT.TB alone [819] | No complete diagnostic algorithm is provided |
| Difficult lower-respiratory infection | Consider mNGS as an adjunct to conventional microbiology [817] | Retrospective, heterogeneous populations |
| Suspected drug resistance | Seek rapid susceptibility data and specialist/programmatic review [814][820][821] | No universal empiric regimen can be inferred |
| Worsening CNS disease after treatment begins | Reassess for paradoxical reaction, failure, resistance, nonadherence, and complications [815]C | No corticosteroid protocol is supplied |
| Treatment interruption risk | Monitor stock and continuity of anti-TB medicines [813] | Mitigation strategies were heterogeneous |
| Household exposure | Prioritize contact-focused evaluation and bacteriological confirmation where indicated [823] | Study-specific population and setting |
Definitive Therapy: Dosing, PK/PD, Duration and De-escalation
- ▸The supplied evidence does not establish a new universal dosing or duration standard for DS-TB, RR/MDR-TB, or TPT. [779,829,834]
- ▸1HP is described as 1 month of daily isoniazid plus rifapentine; the cited pharmacokinetic study used dolutegravir 50 mg once daily and fluconazole 800 mg once daily in adults with advanced HIV disease. [816]
- ▸PK sampling in the 1HP interaction study occurred on days 1, 5, and 14, with measurements before dosing and at 2, 4, 8, and 24 hours. [816]
- ▸Bedaquiline resistance threatens short RR/MDR-TB regimens and requires susceptibility-guided treatment rather than automatic continuation of a bedaquiline-containing regimen. [834]
- ▸Time-to-positivity, TB-MBLA, and other early-response biomarkers are investigational tools for response modeling and do not provide validated bedside de-escalation thresholds. [744,747]
- ▸Digital adherence support has been studied in DS-TB, but the supplied abstract does not show that it permits shortened treatment. [828]
- ▸Frailty, older age, and undernutrition support intensified monitoring and supportive care rather than unvalidated dose reduction. [831,827]
Scope of the updated evidence
The supplied 2026 references provide important implementation, pharmacokinetic, resistance-surveillance, and treatment-response evidence, but they do not establish a new universally applicable dosing schedule for drug-susceptible tuberculosis (DS-TB), rifampicin-resistant/multidrug-resistant tuberculosis (RR/MDR-TB), or tuberculosis preventive treatment (TPT). Consequently, definitive prescribing should remain individualized according to disease site, drug-susceptibility testing (DST), comorbidity, drug–drug interactions, toxicity, and local or national guidelines; the evidence supplied here should not be used to infer unreported doses or to shorten therapy without microbiological and clinical justification. [779][829][834]
Dosing and regimen selection
The clearest dosing evidence concerns 1 month of daily isoniazid plus rifapentine (1HP) as TPT. In adults with advanced HIV disease, a pharmacokinetic study evaluated 1HP alongside once-daily dolutegravir-based antiretroviral therapy containing dolutegravir 50 mg once daily and fluconazole 800 mg once daily for cryptococcal meningitis. [816] The study sampled drug concentrations before dosing and at 2, 4, 8, and 24 hours after dosing on treatment days 1, 5, and 14, allowing assessment of early and evolving exposure during coadministration. [816] The abstract describes 1HP as efficacious, well tolerated, and safe, while also identifying concern about rifapentine drug interactions as an implementation barrier. [816]
For household contacts of patients with drug-resistant tuberculosis, screening and TPT practices vary substantially by country and setting, and the evidence base remains fragmented. [779] The scoping review was designed to synthesize regimens and implementation barriers rather than provide a single definitive dose or duration applicable to every contact. [779] Preventive treatment should therefore follow documented susceptibility information from the source patient when available, contact evaluation, exclusion of active disease, age and pregnancy considerations, HIV status, and interaction assessment; the supplied abstract does not support a more specific regimen hierarchy. [779]
For active RR/MDR-TB, treatment duration and drug selection cannot be inferred from the available cohort abstracts. Bedaquiline resistance is reported as an increasing threat to short RR/MDR-TB regimens, and the Uzbekistan cohort specifically evaluated treatment strategies, sputum culture conversion, mortality, and tuberculosis-free survival in people with bedaquiline-resistant disease. [834] These data support susceptibility-guided regimen construction rather than automatic continuation of a standard bedaquiline-containing regimen when resistance is detected. [834] A retrospective Eritrean cohort likewise describes MDR-TB as associated with high mortality and examines clinical and biochemical predictors, but it does not establish a new dosing algorithm or de-escalation rule. [784]
PK/PD, exposure, and response monitoring
Pharmacokinetic assessment is particularly relevant when rifapentine is combined with antiretroviral therapy or other interacting medicines. The 1HP study’s intensive sampling design provides exposure data for dolutegravir, rifapentine, and fluconazole, but the supplied abstract does not report numerical concentration targets, exposure thresholds, or recommended dose adjustments. [816] Therefore, clinicians should not extrapolate a dose change from the study design alone. [816]
Early bactericidal activity and culture conversion remain pharmacodynamic treatment-response endpoints, but they are imperfectly interchangeable. A pharmacometrics-enabled analysis used time-to-positivity measurements from phase 2a trials to predict 2-month culture conversion and examined data collected through 14 or 28 days after treatment initiation. [744] A separate modeling study evaluated TB-MBLA, colony-forming units, and time-to-positivity jointly in an early bactericidal activity trial, reflecting efforts to improve response characterization when culture-based monitoring is slow or incomplete. [747] These approaches may support trial design and individualized response assessment, but the cited evidence does not validate a bedside threshold for stopping, switching, or de-escalating therapy. [744][747]
Duration and de-escalation
No supplied reference demonstrates that treatment can be safely shortened solely on the basis of early bactericidal activity, time-to-positivity, TB-MBLA, radiographic improvement, symptom resolution, or adherence technology. [744][747][828] The Argentine pragmatic randomized trial evaluated a patient-centred digital adherence tool incorporating daily adherence reporting, bidirectional messaging, educational content, and weekly urine-based isoniazid testing in adults receiving treatment for DS-TB, but the supplied abstract does not provide outcome results establishing that digital support permits shorter therapy or reduced monitoring. [828]
De-escalation in RR/MDR-TB should be considered only after confirmation of the full susceptibility profile, sustained microbiological response, clinical stability, and a regimen-specific assessment of resistance emergence and toxicity. Bedaquiline resistance specifically argues against assuming that a short regimen remains effective when a core drug is inactive. [834] Frailty, older age, undernutrition, and severe disease may increase the risk of poor outcomes and complicate tolerability: laboratory-based frailty was studied as a predictor of unfavorable outcomes in older adults with DS-TB, while undernutrition was investigated among patients with TB in Somalia. [831][827] These findings support closer monitoring and nutritional or supportive interventions rather than unvalidated dose reduction. [831][827]
Adjunctive corticosteroids are relevant to tuberculous meningitis, not routine pulmonary TB; a 2026 systematic review and meta-analysis evaluated mortality and adverse outcomes across randomized and quasi-randomized studies. [836] Ocular TB may also require site-specific management, as a reported presumed ocular TB case initially resembling acute retinal necrosis worsened despite antiviral therapy and subsequently followed an antituberculous treatment pathway. [786]C Such extrapulmonary presentations require specialist-directed treatment and should not be de-escalated using pulmonary response criteria alone. [786]C
Practical evidence-based rule
Use the shortest validated regimen only when active disease status, DST, drug exposure considerations, and clinical response support it; otherwise, maintain definitive therapy and monitoring according to the applicable guideline. The supplied evidence supports improved DST, PK assessment, adherence support, and response modeling, but does not supply new universal dose, duration, therapeutic-drug-monitoring target, or de-escalation threshold. [779][816][829][744][747][828][834]
| Clinical issue | Evidence supplied | Implication |
|---|---|---|
| 1HP TPT | Daily isoniazid plus rifapentine for 1 month; evaluated with dolutegravir 50 mg daily and fluconazole 800 mg daily | Assess interactions and follow validated regimen guidance; no additional dose adjustment can be inferred from the abstract. [816] |
| RR/MDR-TB with bedaquiline resistance | Resistance threatens short regimens; treatment strategies and culture conversion were evaluated retrospectively | Reconstruct therapy using current DST and active-drug principles; do not assume standard short-regimen efficacy. [834] |
| Early response biomarkers | Time-to-positivity, TB-MBLA, and culture-based measures were modeled | Useful for research and response characterization, but not validated as stopping thresholds. [744][747] |
| Adherence technology | Digital reporting, messaging, education, and urine isoniazid testing were evaluated | May support adherence, but does not itself justify shortened therapy. [828] |
History and Evolution of Treatment
- ▸The supplied evidence does not document historical milestones involving individual tuberculosis drugs or standard multidrug regimens [812] [745] [839] [840] [846].
- ▸Digital adherence support now combines daily reporting, two-way messaging, education, and weekly urine-based isoniazid verification [828].
- ▸Risk prediction is being used to identify patients vulnerable to loss to follow-up during drug-resistant tuberculosis treatment [838].
- ▸Recognition of heteroresistance is driving interest in more sensitive resistance-detection technologies [845].
- ▸Pharmacometrics and machine learning are being applied to early bactericidal-activity biomarkers and **2-month culture conversion** prediction [744].
- ▸In-home tongue-swab and urine lipoarabinomannan testing broaden access beyond sputum-dependent diagnosis [837] [843].
- ▸Modern tuberculosis care increasingly incorporates HIV-programme infrastructure and community advisory boards [830] [844].
Scope of the available evidence
The supplied literature does not provide a conventional chronological account of tuberculosis treatment—for example, it does not document the introduction of individual first-line drugs, multidrug short-course regimens, directly observed therapy, or bedaquiline-based treatment. Several supplied references concern non-tuberculosis conditions, including vitiligo, ANCA-associated vasculitis, lung cancer, connective-tissue-disease interstitial lung disease, and COPD prediction models, and therefore do not establish historical tuberculosis-treatment milestones [812] [745]C [839] [840] [846]D. The evidence instead illustrates the contemporary evolution of tuberculosis care from drug administration alone toward integrated adherence support, precision trial design, resistance surveillance, decentralised diagnosis, community participation, and risk-based follow-up.
From treatment delivery to patient-centred adherence support
A major modern development is the use of digital tools to address treatment adherence. In a pragmatic randomised trial in four public hospitals in Buenos Aires, 555 adults aged ≥16 years with newly diagnosed drug-susceptible tuberculosis were assigned to standard care or standard care plus Tuberculosis Treatment Support Tools (TB-TST) [828]. The intervention combined daily adherence reporting, bidirectional messaging with treatment supporters, educational material, and a weekly urine-based isoniazid test for adherence verification [828]. This model represents an evolution from passive clinic-based monitoring toward continuous, patient-centred support that combines self-reporting, communication, education, and biochemical confirmation [828].
The need for such approaches is particularly evident in drug-resistant tuberculosis, where loss to follow-up can prolong transmission, worsen outcomes, and permit further amplification of resistance [838]. A multicentre retrospective study in Ethiopia used records from 1,097 patients treated for drug-resistant tuberculosis between 2010 and 2025 to develop and internally validate a clinical risk score for loss to follow-up [838]. Risk prediction therefore adds a preventive layer to treatment programmes: patients at elevated risk can potentially be identified earlier for targeted counselling, social support, or intensified monitoring [838].
From empirical treatment to resistance-informed care
Contemporary tuberculosis management increasingly recognises that resistance may exist below the detection threshold of routine testing. Heteroresistance is defined by the coexistence of susceptible and resistant subpopulations within the same Mycobacterium tuberculosis population [845]D. Because the resistant fraction may be small, routine diagnostic methods can miss it, allowing selection during therapy and contributing to treatment failure or relapse [845]D. The field is consequently moving toward more sensitive molecular and phenotypic methods capable of detecting minority resistant populations before they become clinically dominant [845]D.
Treatment-development methodology has also become more quantitative. Phase 2a tuberculosis trials traditionally evaluate early bactericidal activity over approximately 2 weeks, often using time to positivity, before phase 2b studies assess culture conversion over about 8 weeks [744]. Pharmacometrics-enabled machine-learning analyses of REMoxTB data have been used to model baseline and treatment-related changes in time to positivity and predict 2-month culture conversion [744]. This approach may improve regimen selection, optimise trial duration, and identify early biomarkers of later treatment response [744].
Expansion beyond sputum-dependent treatment pathways
Although diagnosis is not itself treatment, diagnostic evolution directly affects who can access effective therapy. Household-contact investigations have traditionally depended on clinic attendance and sputum collection, which can limit case detection [837]C. A prospective cohort study in South Africa evaluated in-home tongue-swab molecular testing among household contacts of drug-sensitive pulmonary tuberculosis index patients, reflecting a shift toward household-level screening and earlier linkage to care [837]C. Similarly, a next-generation urine lipoarabinomannan assay was evaluated in outpatient adults in South Africa and Uganda regardless of HIV status, addressing the limitations of sputum-dependent testing, particularly among people living with HIV [843]D. Case-based reports also emphasise that extrapulmonary tuberculosis may present without pulmonary symptoms and mimic other diseases, requiring early consideration so that treatment is not delayed [842]C.
Integration with HIV care and community governance
Tuberculosis treatment has increasingly evolved within broader HIV and health-system programmes. The Caribbean, Central and South America Network for HIV Epidemiology has supported two decades of regional HIV research and policy development, providing infrastructure relevant to managing intersecting HIV and tuberculosis burdens [830]. Community participation has also become more institutionalised: community advisory boards, initially mobilised by HIV activists, have been incorporated into tuberculosis research governance to create formal spaces for patient and community involvement [844]D. This reflects a transition from a purely biomedical treatment model toward one that includes accountability, representation, and community-defined priorities [844]D.
Current direction
The current trajectory is therefore toward treatment that is digitally supported, resistance-aware, biomarker-guided, diagnostically decentralised, and socially accountable. Evidence from SARS-CoV-2-era cohorts also shows that investigators continue to examine how pre-existing immune responses, including anti-RBD antibody levels after vaccination or infection, relate to tuberculosis-treatment outcomes during the first 2 months of therapy [841]. These developments complement—not replace—the need for microbiologically appropriate regimens, reliable adherence, early detection of resistance, and sustained follow-up [828] [841] [845]D.
| Evolutionary focus | Contemporary evidence | Treatment implication |
|---|---|---|
| Adherence | Digital reporting, messaging, education, and weekly urine isoniazid testing [828] | More continuous and patient-centred support |
| Retention in care | Clinical risk score for drug-resistant tuberculosis loss to follow-up [838] | Earlier targeting of enhanced support |
| Resistance | Detection of minority susceptible and resistant subpopulations [845]D | Greater emphasis on heteroresistance-aware testing |
| Regimen development | Time-to-positivity modelling and prediction of 2-month culture conversion [744] | More efficient biomarker-guided trials |
| Case finding | Home tongue-swab and urine lipoarabinomannan testing [837]C [843]D | Earlier linkage to treatment for people missed by sputum pathways |
| Governance | HIV-linked research infrastructure and community advisory boards [830] [844]D | Greater integration of systems and community priorities |
Antimicrobial Resistance and Stewardship
- ▸Mycobacterial resistance involves low cell-envelope permeability, efflux, drug-modifying enzymes, biofilms, and adaptive stress responses [855].
- ▸Antibiotic heteroresistance is an expanding research concern and may permit resistant subpopulations to evade routine detection [849].
- ▸Rapid molecular testing should be integrated with culture, line-probe assays, and phenotypic susceptibility testing, especially in paucibacillary TB meningitis [799][797].
- ▸Bedaquiline resistance threatens short MDR/RR-TB regimens and requires careful construction of multidrug regimens containing several expected active agents [834].
- ▸Stock-out prevention and interventions for loss to follow-up are core components of antimicrobial stewardship [813][838].
- ▸Rifamycin-based LTBI therapy can affect antiretroviral resistance management in people with HIV [851].
Scope and determinants
Antimicrobial resistance (AMR) remains a major threat to tuberculosis (TB) control because resistance can compromise effective multidrug therapy, prolong infectiousness, increase toxicity and cost, and facilitate onward transmission. Evidence from Ecuador’s 2000–2024 systematic review shows that AMR research is expanding but remains fragmented, predominantly hospital-based, urban, and concentrated in the human-health sector, with limited rural, Amazonian, and insular representation [848]. Although that review addressed bacterial AMR broadly rather than TB alone, its One Health framework is relevant to TB stewardship because surveillance gaps across communities, animals, food, and the environment can obscure transmission and selective pressures [848].
Mycobacterial resistance reflects both intrinsic and acquired mechanisms, including the low permeability of the mycobacterial cell envelope, efflux pumps, drug-modifying enzymes, biofilm formation, and stress-induced adaptive responses [855]D. Antibiotic heteroresistance—coexistence of susceptible and resistant subpopulations—has become an increasingly prominent research area; a bibliometric analysis identified 1,516 publications and reported marked growth in output and citations over the past two decades [849]. Heteroresistance is clinically important because routine testing may under-detect resistant subpopulations, potentially allowing treatment failure and further resistance emergence [849].
Surveillance and rapid resistance detection
Prompt identification of resistance is essential for selecting an active regimen and limiting inappropriate exposure to ineffective drugs [799]D. A multiplex open real-time PCR evaluation in a high-burden setting simultaneously assessed Mycobacterium tuberculosis complex (MTBc), nontuberculous mycobacteria, and first-line drug resistance; MTBc detection showed 100% sensitivity and 100% specificity in the evaluated sample set, while nontuberculous mycobacteria detection had 70.0% sensitivity and 100% specificity [799]D. These findings support integrated molecular pathways, but the assay should be interpreted alongside culture, antigen testing, line-probe assays, and phenotypic drug-susceptibility testing because the study used composite reference standards and evaluated a defined specimen set [799]D.
Drug-resistance testing can be particularly vulnerable to diagnostic attrition in tuberculous meningitis, where cerebrospinal-fluid specimens are often paucibacillary and available only in small volumes [797]. A laboratory-based study in Northern India evaluated a cascade involving cartridge-based nucleic-acid amplification, liquid culture, line-probe assays, and phenotypic susceptibility testing, highlighting the need to preserve specimens and use complementary tests when resistance is suspected [797]. Resistance profiles also vary geographically: a five-year hospital study in Guizhou, China characterized phenotypic resistance patterns among 9,389 hospitalized pulmonary-TB patients from 2018–2023, while a separate GBD-2023 analysis identified China, India, and Russia among the countries with the largest absolute MDR/XDR-TB burdens [821][852].
Regimen selection and emerging resistance
For isoniazid mono-resistant pulmonary TB, a prospective Korean national-program cohort evaluated the WHO-recommended 6-month fluoroquinolone-containing FqREZ regimen against alternative non-fluoroquinolone regimens in adults treated between 2016 and 2024; the principal outcome was treatment success without recurrence during 12 months after completion, with serious adverse events assessed as a secondary outcome [814]. This real-world evidence addresses effectiveness and safety but should not be extrapolated to rifampicin-resistant or multidrug-resistant TB [814].
Bedaquiline resistance is an especially serious stewardship concern because it threatens the effectiveness of short regimens for rifampicin-resistant and multidrug-resistant TB [834]. A retrospective cohort from Karakalpakstan, Uzbekistan, described treatment strategies, susceptibility profiles, time to sustained sputum-culture conversion, mortality, and 18-month tuberculosis-free survival among people with bedaquiline-resistant TB treated from 2017 to June 2025 [834]. These data reinforce the need to avoid functional monotherapy, obtain resistance testing when feasible, and construct regimens from multiple drugs expected to be active; the cited cohort, however, was retrospective and region-specific [834]. Pediatric implementation also requires formulation and pharmacokinetic stewardship: a study evaluated a novel 50-mg clofazimine tablet and revised once-daily weight-banded dosing in children under 18 years and under 30 kg receiving MDR/RR-TB treatment [854]D.
Programmatic stewardship and patient support
Medicine availability is itself a stewardship determinant. A systematic review of antiretroviral, anti-TB, and antimalarial stock-outs in low- and middle-income countries examined causes, consequences, and mitigation strategies, emphasizing that interruptions in supply can affect both health-system performance and patient outcomes [813]. Preventing stock-outs therefore requires reliable forecasting, procurement, distribution, buffer stocks, and communication with treatment programs when substitutions are unavoidable [813].
Loss to follow-up during drug-resistant-TB treatment can cause treatment interruption, ongoing transmission, resistance amplification, and increased morbidity and mortality [838]. A multicenter Ethiopian study used records from 1,097 DR-TB patients treated between 2010 and 2025 to develop and internally validate a clinical risk score for loss to follow-up [838]. Such tools may support targeted adherence interventions, although internal validation does not establish transportability to other settings [838]. A retrospective Eritrean cohort of 257 MDR/RR-TB patients treated from 2013–2023 examined mortality and associated clinical, hematologic, and biochemical factors, demonstrating the continuing need for outcome monitoring in high-burden programs [784].
Special populations and interaction risks
In people with HIV, rifamycin-based latent-TB infection treatment can interact with antiretroviral therapy; a reported case documented emergence of integrase-strand-transfer-inhibitor resistance after LTBI treatment, illustrating the importance of reviewing archived genotypes and carefully modifying antiretroviral regimens [851]C. Delayed recognition of pulmonary TB during immunosuppression for suspected connective-tissue disease can also postpone appropriate diagnosis and treatment, as illustrated by a case involving sequential glucocorticoid, belimumab, tocilizumab, and baricitinib exposure [758]C. Pediatric CNS-TB paradoxical reactions may mimic treatment failure after initial improvement; a longitudinal cohort of 57 HIV-negative children receiving standard therapy assessed these reactions and six-month functional outcomes [815]C. Clinicians should therefore distinguish inflammatory worsening from microbiologic resistance using clinical, imaging, and microbiologic reassessment [815]C.
Stewardship priorities
Priority actions are integrated molecular and phenotypic resistance surveillance, protection against drug stock-outs, regimen construction using multiple active agents, pharmacokinetic optimization in children, early identification of adherence risk, and explicit assessment of rifamycin–antiretroviral interactions [799]D[813][838][854]D[851]C. National and international surveillance should also account for regional heterogeneity and expand beyond urban hospitals, particularly in underserved geographic areas [848].
| Priority | Evidence and implication |
|---|---|
| Resistance detection | Multiplex PCR can streamline MTBc and first-line resistance detection, but complementary testing remains important [799]D. |
| CNS-TB testing | Limited CSF volume and paucibacillary disease create diagnostic attrition; use a complementary testing cascade [797]. |
| Regimen protection | Bedaquiline resistance threatens short RR/MDR-TB regimens; avoid regimens with too few active drugs [834]. |
| Supply continuity | Stock-outs affect treatment programs and patient outcomes; strengthen forecasting, procurement, and distribution [813]. |
| Retention in care | Risk prediction may enable earlier adherence support for DR-TB patients at risk of loss to follow-up [838]. |
| Pediatric dosing | Weight-banded clofazimine dosing and a 50-mg tablet may improve pediatric formulation accuracy [854]D. |
Complications
- ▸Post-TB pulmonary sequelae may include fibrosis, bronchiectasis, and residual cavities detectable at least 6 months after treatment completion. [863]
- ▸TBM may have case fatality of up to 50% in resource-limited settings and may be complicated by hydrocephalus, visual or auditory impairment, gastrointestinal bleeding, and joint disorders. [836]
- ▸Linezolid toxicity in complex and drug-resistant TB is principally haematological and neurological and may require treatment modification. [795]
- ▸Loss to follow-up in DR-TB can promote ongoing transmission, resistance amplification, morbidity, and mortality. [838]
- ▸Frailty and undernutrition are important contributors to poor functional and treatment outcomes, particularly in older patients with spinal TB and patients with low BMI. [858][860]
Tuberculosis complications vary according to the site of disease, host vulnerability, nutritional status, treatment regimen, and drug resistance. Drug-resistant tuberculosis (DR-TB) is associated with poorer treatment success and increased mortality than drug-susceptible disease, while ongoing household transmission increases the risk of infection and progression to active disease among close contacts. [779] Malnutrition is an important determinant of TB incidence, progression, and treatment outcome, including in high-income settings. [860]
Pulmonary and post-tuberculosis complications
Pulmonary TB may leave persistent structural and functional abnormalities after microbiological treatment completion. In a prospective study of adults evaluated at least 6 months after treatment, post-TB structural sequelae were defined by fibrosis, bronchiectasis, or residual cavities on high-resolution computed tomography; these abnormalities were assessed together with dyspnoea, respiratory function, and respiratory health status. [863] Such sequelae represent an important source of chronic respiratory morbidity among TB survivors and may require long-term respiratory assessment. [863]
Residual cavitation and bronchiectasis may also contribute to persistent respiratory symptoms and impaired health status after treatment, although the available study was cross-sectional and does not establish causality or quantify risk for individual patients. [863] Patients with substantial post-TB structural disease should therefore be evaluated for persistent airflow or gas-exchange impairment, exercise limitation, recurrent infection, and other chronic respiratory disorders on the basis of symptoms and pulmonary testing. [863]
Neurological complications
Tuberculous meningitis (TBM) is a severe extrapulmonary complication with reported case fatality of up to 50% in resource-limited settings despite standard anti-TB therapy. [836] Major complications evaluated in the evidence base include hydrocephalus, visual impairment, auditory impairment, gastrointestinal bleeding, and joint disorders. [836] Neurological injury may therefore persist even when treatment is completed, making assessment of vision, hearing, cognition, motor function, and cerebrospinal-fluid or imaging abnormalities clinically important when indicated. [836]
Adjunctive corticosteroids are widely recommended for TBM, but a systematic review and meta-analysis of 11 randomized or quasi-randomized trials found that the effects on mortality and safety varied across populations and remained imprecisely defined. [836] The review specifically examined all-cause mortality, gastrointestinal bleeding, visual and auditory impairment, hydrocephalus, and joint disorders, with certainty assessed using GRADE. [836] Corticosteroid use should consequently be individualized and monitored for treatment-related complications, particularly gastrointestinal bleeding and other clinically relevant adverse effects. [836]
Treatment-related toxicity
Drug toxicity is a major complication of prolonged or complex TB treatment. Linezolid, commonly used in DR-TB and other complex TB regimens, is limited by haematological and neurological toxicities; these adverse effects may necessitate dose modification or discontinuation. [795] Real-world experience has examined contezolid as a possible salvage option after linezolid intolerance and as a proactive alternative for patients considered at high risk of linezolid-related adverse events, but the available evidence remains retrospective. [795]
A six-month fluoroquinolone-containing regimen for isoniazid mono-resistant pulmonary TB has been evaluated in prospective real-world practice, with treatment success without recurrence within 12 months after completion as the primary favorable outcome and serious adverse events as a secondary outcome. [814] This evidence supports monitoring for serious regimen-related events, but the abstract does not provide sufficient event-level data to define the frequency or nature of individual complications. [814]
Drug-resistant disease and treatment failure
DR-TB can result in prolonged infectiousness, treatment failure, recurrence, death, and amplification of resistance when therapy is ineffective or interrupted. [779] Loss to follow-up is a major complication of DR-TB management because it may lead to continued transmission, further drug-resistance amplification, increased morbidity, and mortality. [838] A multicentre Ethiopian study developed and internally validated a clinical risk score for loss to follow-up using records from 1,097 DR-TB patients treated between 2010 and 2025; external validation is still required before broad implementation. [838]
In Eritrea, a retrospective cohort of 257 patients with multidrug-resistant or rifampicin-resistant TB evaluated mortality and associated demographic, haematological, and biochemical factors over 2013–2023. [784] These findings reinforce the importance of monitoring systemic illness and laboratory abnormalities in MDR/RR-TB, although retrospective regional data should not be generalized to all settings. [784]
Frailty, disability, and nutritional complications
Older adults with spinal TB may develop frailty because of chronic inflammation, nutritional depletion, pain, and activity limitation. [858] Frailty is associated with adverse outcomes such as prolonged hospitalization, functional decline, and mortality, and a single-centre model was developed and internally validated to identify Fried frailty using early in-hospital clinical information. [858] Spinal TB should therefore prompt assessment of mobility, nutrition, functional status, falls risk, and discharge support, particularly in older patients. [858]
Undernutrition at treatment initiation is associated with adverse TB outcomes, and a multicentre Italian cohort specifically examined outcome differences across BMI categories including <16 kg/m², 16–16.99, 17–18.49, 18.5–24.99, and ≥25 kg/m². [860] Nutritional assessment and support should be integrated into TB care rather than treated as an ancillary intervention. [860]
Complications in contacts and immunocompromised patients
Household contacts of patients with DR-TB have increased risk because of prolonged exposure, and inadequate screening or preventive treatment may permit progression from infection to disease and sustain household transmission. [779] Contact evaluation should therefore include systematic screening and consideration of TB preventive treatment based on resistance pattern, local guidance, and individual risk. [779] In patients with AIDS, distinguishing TB from non-tuberculous mycobacterial infection can be diagnostically difficult; plasma extracellular-vesicle microRNA profiles are being investigated as potential diagnostic and differential-diagnostic biomarkers, but this approach remains investigational. [781]C
| Complication domain | Evidence-based manifestations or risks | Clinical implication |
|---|---|---|
| Post-TB lung disease | Fibrosis, bronchiectasis, residual cavities, dyspnoea, and impaired respiratory health status. [863] | Assess persistent symptoms and pulmonary impairment after treatment. [863] |
| Tuberculous meningitis | Mortality up to 50% in some resource-limited settings; hydrocephalus, visual or auditory impairment, gastrointestinal bleeding, and joint disorders. [836] | Monitor neurological, visual, auditory, and treatment-related complications. [836] |
| Drug toxicity | Linezolid-associated haematological and neurological toxicity. [795] | Monitor blood counts and neurological status; consider regimen modification when intolerance occurs. [795] |
| DR-TB treatment failure or interruption | Continued transmission, resistance amplification, morbidity, mortality, and recurrence risk. [779][838] | Identify loss-to-follow-up risk and provide adherence support. [838] |
| Frailty and undernutrition | Functional decline, prolonged hospitalization, mortality, and adverse TB outcomes. [858][860] | Integrate nutritional, functional, and geriatric assessment. [858][860] |
Prognosis and Natural History
- ▸Patient delay is recognized as a contributor to higher TB mortality; a 2026 meta-analysis included 42 studies and 492,448 patients, although pooled estimates were not supplied. [780]
- ▸Delayed sputum-smear conversion was defined as persistent positivity beyond 8 weeks in a study evaluating hepatic steatosis as a treatment-response factor. [822]
- ▸The recommended fluoroquinolone-containing regimen for isoniazid mono-resistant pulmonary TB was evaluated over 6 months, with recurrence assessed for 12 months after treatment completion. [814]
- ▸Drug-resistant TB cohorts assessed mortality, sustained culture conversion, serious adverse events, and TB-free survival, including an 18-month outcome definition for bedaquiline-resistant disease. [784][834]
- ▸HIV-associated MTB bloodstream infection remains a major prognostic concern, and tuberculin responsiveness was studied as a possible accessible marker in hospitalized HIV-positive patients. [864][810]
- ▸TB meningitis may have case-fatality rates up to 50% in resource-limited settings; corticosteroids were evaluated in an 11-trial systematic review. [836]
- ▸Pediatric CNS TB paradoxical reactions were defined after at least 10 days of treatment and functional outcome was assessed at 6 months. [815]
- ▸Post-TB lung changes may influence COPD exacerbations and mortality, while diagnostic uncertainty can result from NTM disease or false-negative T-SPOT.TB results. [809][751][819]
Tuberculosis (TB) has a highly variable natural history. Prognosis depends on the anatomical site and severity of disease, drug susceptibility, HIV and other comorbidities, nutritional and immune status, speed of diagnosis, treatment adherence, and the development of treatment-related or paradoxical complications. The available updated evidence is largely derived from observational cohorts and systematic reviews; several supplied abstracts describe study methods but do not provide complete numerical outcome data.
Factors influencing outcome
Diagnostic delay is clinically important because delayed recognition prolongs untreated disease and may increase the risk of severe illness and death. A 2026 meta-analysis of 42 studies involving 492,448 patients evaluated factors associated with patient delay, defined as delay before seeking or obtaining care, and specifically framed delay as a contributor to higher mortality. The review searched literature through 2025 and used formal heterogeneity, publication-bias, and study-quality assessments; however, the supplied abstract does not report the pooled effect estimates or the individual determinants identified. [780]
Host comorbidity and metabolic status may affect recovery. In a Korean cohort, TB-related hospitalization was evaluated according to comorbidity burden using Kaplan–Meier and Cox regression methods; the study included patients diagnosed between 2024 and 2025, but the supplied abstract does not provide hospitalization rates or adjusted hazard ratios. [865]C Hepatic steatosis was investigated in newly diagnosed, smear-positive pulmonary TB patients treated with standard therapy. Delayed smear conversion was defined as persistent positivity beyond 8 weeks after treatment initiation; the study collected demographic, clinical, ultrasonographic, laboratory, and cytokine variables, but the supplied abstract does not state the magnitude of the association between steatosis and delayed conversion. [822]
Post-TB structural lung disease can have consequences beyond microbiological cure. In a population-based retrospective cohort of adults with chronic obstructive pulmonary disease (COPD), both active TB and post-TB lung changes were examined in relation to COPD exacerbations and mortality. The study used routinely collected regional healthcare data and identified TB using ICD-10 codes A15–A19; the supplied abstract establishes the prognostic question but does not report the cohort’s effect estimates. [809]
Drug-susceptible and drug-resistant pulmonary TB
In a pragmatic randomized trial from four public reference hospitals in Buenos Aires, 555 adults with newly diagnosed drug-susceptible TB were randomized to standard care or standard care plus a patient-centred digital adherence tool. The intervention provided daily adherence reporting, two-way messaging with treatment supporters, educational material, and weekly urine-based isoniazid verification. The trial directly assessed whether this approach improved treatment outcomes, but the supplied abstract does not include the comparative success, failure, loss-to-follow-up, or mortality results. [828]
For isoniazid mono-resistant pulmonary TB, a multicentre prospective Korean cohort compared the World Health Organization-recommended 6-month fluoroquinolone-containing FqREZ regimen with alternative non-fluoroquinolone regimens. The primary endpoint was a favourable outcome, defined as treatment success without recurrence during 12 months after treatment completion; serious adverse events were a secondary endpoint. The supplied abstract does not provide the comparative favourable-outcome estimate or safety results. [814]
Drug resistance is associated with a more difficult and potentially less favourable disease course. A retrospective Eritrean cohort reviewed 257 patients with multidrug-resistant or rifampicin-resistant TB treated between 2013 and 2023, using Kaplan–Meier and multivariable Cox regression to examine mortality and associated haematological, biochemical, demographic, and clinical factors; numerical mortality estimates and independent predictors are not included in the supplied abstract. [784] Bedaquiline resistance threatens the effectiveness of short regimens for rifampicin-resistant or multidrug-resistant TB. A retrospective cohort in Karakalpakstan, Uzbekistan, examined treatment strategies, sustained sputum-culture conversion, mortality, and TB-free survival 18 months after bedaquiline-resistant TB diagnosis; TB-free survival required being alive and either having completed treatment or remaining in care, with sustained culture conversion. The supplied abstract does not report the observed proportions. [834]
HIV-associated disseminated disease
HIV-associated TB remains a major cause of mortality, particularly when Mycobacterium tuberculosis bloodstream infection (MTB-BSI) is present. A multicountry prospective cohort enrolled adults with HIV from seven countries in Africa and Asia, including inpatients irrespective of TB symptoms and symptomatic outpatients, to assess MTB-BSI prevalence and early mortality in the era of widespread antiretroviral therapy. Participants had received fewer than three doses of TB treatment in the preceding 60 days and no recent isoniazid preventive therapy; the supplied abstract does not provide prevalence or mortality estimates. [864]
Tuberculin responsiveness was evaluated as a potentially accessible prognostic marker in 107 hospitalized HIV-positive adults with pulmonary TB. The study assessed Mantoux reactivity and nutritional status, including body-mass index, in relation to clinical status at hospital follow-up. The abstract does not report whether tuberculin response independently predicted outcome. [810]C
Central nervous system and extrapulmonary TB
Tuberculous meningitis (TBM) carries particularly high mortality, with case-fatality rates reported as up to 50% in resource-limited settings despite standard anti-TB therapy. A systematic review and meta-analysis of 11 randomized or quasi-randomized trials assessed adjunctive corticosteroids for mortality and complications including gastrointestinal bleeding, visual or auditory impairment, hydrocephalus, and joint disorders, using GRADE certainty assessment. The supplied abstract does not include the pooled effect sizes. [836]
In a prospective longitudinal cohort of 57 HIV-negative children aged 6 months to 14 years with CNS TB, paradoxical reactions were defined as new or worsening lesions or symptoms after initial improvement following at least 10 days of therapy. Clinical assessment, cerebrospinal-fluid analysis, and neuroimaging were performed at baseline and during deterioration or at 8 weeks, with functional outcome assessed at 6 months using the Pediatric Cerebral Performance Category scale. The supplied abstract does not state the incidence of paradoxical reactions or their effect on functional outcome. [815]C
The burden of TBM may be underestimated because diagnosis is difficult after death. A prospective Zambian adult cohort used minimally invasive tissue sampling in deceased patients presenting with meningitis symptoms to establish the contribution of TBM when complete diagnostic autopsy was uncommon. Patients were followed to discharge or death; the supplied abstract does not report the confirmed postmortem TBM proportion. [746]C
Diagnostic uncertainty and alternative diagnoses
Prognosis can be affected by misclassification. In a multicentre Indian study of people with presumptive TB, investigators characterized nontuberculous mycobacterial disease, including clinical features, underlying conditions, species distribution, and treatment outcomes; participants were aged 12 years or older, recruited from 2021–2025, and concurrent TB was excluded. The supplied abstract does not provide species-specific outcomes. [751] False-negative T-SPOT.TB results may delay diagnosis in bacteriologically confirmed pulmonary TB. A retrospective cohort of 4,931 adults in China examined demographic, comorbidity, radiological, inflammatory, and T-cell factors associated with false-negative results; the supplied abstract does not report the identified predictors. [819]
Finally, a South African prospective household-contact cohort evaluated in-home tongue-swab molecular screening and linkage to care among adults exposed to drug-sensitive pulmonary TB. This evidence informs earlier detection of secondary cases, but the supplied abstract does not provide diagnostic-accuracy or linkage estimates. [837]C A case report illustrates the potential severity of delayed recognition in isolated renal TB: a 77-year-old man with diabetes had destructive renal disease complicated by a perinephric abscess, nephrocutaneous fistula, renal replacement lipomatosis, and synchronous clear-cell renal-cell carcinoma. [866]C
Overall, current evidence supports early diagnosis, susceptibility-directed therapy, adherence support, careful management of HIV and comorbid disease, and active surveillance for neurologic, paradoxical, relapse, and post-TB pulmonary complications. The supplied studies provide important prognostic domains, but many abstracts do not report sufficient numerical results to quantify risk for individual patients. [780][828][814][815]C[864][834][836]
| Domain | Evidence and outcome assessed |
|---|---|
| Diagnostic delay | Meta-analysis of patient-delay factors and relationship to mortality risk. [780] |
| Treatment adherence | Randomized evaluation of digital adherence support in drug-susceptible TB. [828] |
| Drug susceptibility | Treatment success, recurrence, serious adverse events, mortality, and culture conversion in resistant TB. [814][784][834] |
| HIV and dissemination | MTB bloodstream infection prevalence and early mortality; tuberculin responsiveness and clinical outcome. [864][810]C |
| CNS TB | Mortality, neurologic complications, paradoxical reactions, and 6-month function. [815]C[836][746]C |
| Long-term sequelae | COPD exacerbations and mortality associated with TB or post-TB lung changes. [809] |
| Diagnostic misclassification | NTM outcomes, false-negative T-SPOT.TB results, and household-contact screening. [751][819][837]C |
Prevention and Infection Control
- ▸Use context-adapted TB prevention in KTRs, especially in high-burden African settings with limited microbiological surveillance. [764]
- ▸Interpret LTBI tests according to exposure, BCG status, geography, and immune status; TST and IGRA were compared across 95 studies involving 63,988 HCWs and first responders. [232]
- ▸Before immunosuppression, assess symptoms and exposure and use TB testing, imaging, vaccination review, and follow-up; repeat TST after 1–4 weeks may be used when the initial result is 0–4 mm in patients with IEI. [783]
- ▸Investigate contacts promptly and consider window prophylaxis for exposed children younger than 5 years. [876]
- ▸Maintain routine childhood immunization in households affected by TB or MDR-TB and address delayed vaccination. [877]
- ▸In HIV-associated TB, monitor for TB-IRIS after ART, particularly with disseminated TB or a short TB-treatment-to-ART interval. [868]
Risk-adapted prevention
Tuberculosis (TB) prevention should be integrated with broader infection-control planning and adapted to epidemiological context, host immune status, exposure intensity, and available diagnostic capacity. Infectious complications are a major cause of morbidity and mortality among kidney transplant recipients (KTRs) in Africa, where immunosuppression occurs alongside high TB burden, endemic pathogens, constrained resources, and limited microbiological surveillance. A 2015–2025 scoping review specifically emphasized context-adapted prophylaxis strategies for African KTRs, although the available abstract does not provide pooled estimates or a single prophylactic regimen. [764] The high burden of multidrug-resistant TB (MDR-TB) in sub-Saharan Africa (SSA) warrants targeted prevention strategies informed by demographic, clinical, socioeconomic, and behavioral characteristics associated with resistance; these characteristics were synthesized in a systematic review and meta-analysis of observational studies published from 2000 through November 2025. [867]
Prevention programs should prioritize early identification of latent TB infection (LTBI) and active disease in groups with increased exposure or impaired immunity. Healthcare workers (HCWs) and first responders are important occupational-risk populations: a meta-analysis included 95 studies from 41 countries and 63,988 participants and compared interferon-gamma release assays (IGRAs) with tuberculin skin tests (TSTs), stratifying results by diagnostic method and World Health Organization TB-incidence region. [232]B2a In foreign-born individuals entering prison in Catalonia, TST performance was assessed against IGRA after current TB had been excluded by clinical and radiological evaluation; BCG vaccination status was evaluated using records, scar assessment, and the BCG World Atlas. [871] In high-BCG settings, interpretation of TST results may require context: a historical school-screening cohort in China evaluated whether an induration threshold of ≥15 mm, among adolescents already measuring ≥10 mm, provided additional risk stratification across routine screening, outbreak-contact, and previously cured-TB contexts. [875]
Screening before immunosuppression
Patients with inborn errors of immunity (IEI) require systematic assessment because TB burden and the performance of screening tests may differ from those in immunocompetent populations. A single-center cohort of 117 adults with IEI used exposure history, symptom assessment, TST, repeat TST after 1–4 weeks when the initial induration was 0–4 mm, and chest imaging with radiography and computed tomography when available. Patients underwent clinical evaluation for TB, treatment when indicated, and follow-up. [783]C
Imported-infection screening is also relevant before pediatric immunosuppressive therapy. A structured protocol in a Madrid tertiary hospital included TB testing, serology, stool analysis, and vaccination assessment, but only 19% of 63 screened children completed the full protocol; at least one infection was detected in 28.6%, with toxoplasmosis reported among the principal findings. [873] These findings support active follow-up of incomplete screening rather than relying solely on protocol availability. [873]
Vaccination and special populations
BCG remains a central TB-prevention intervention in many settings, but administration requires special consideration in infants exposed in utero to tumor necrosis factor-α inhibitors. A retrospective study evaluated the risk of disseminated TB and other infections after neonatal BCG in this population; the introduction notes that recent guidelines recommend deferring live attenuated vaccines such as BCG until 6–12 months of age because of safety concerns and conflicting evidence. [872] BCG-associated immune responses are biologically heterogeneous: genetic analysis in Danish children examined variants associated with circulating inflammatory proteins after vaccination at month 13, identifying 11 independent genome-wide significant loci and four loci supported by follow-up statistical analyses. [878]D These genetic findings are investigational and do not establish an individualized vaccination strategy. [878]D
Routine childhood immunization should be maintained in households affected by TB, including MDR-TB. A secondary analysis of the TB-CHAMP randomized trial assessed coverage and timeliness of vaccines due by 12 months of age among children younger than 5 years enrolled at five South African sites between 2017 and 2023. [877] Vaccine timing is especially important for children living with HIV or TB because delayed or missed routine immunization may increase vulnerability to vaccine-preventable disease. [877]
Contact investigation and healthcare-facility control
Exposure investigations should include rapid identification of contacts, communication with affected families, clinical evaluation, and preventive therapy when indicated. During a 2025 pulmonary-TB response in an Alaskan maternity unit, 282 individuals were identified through contact tracing, 92.9% of contacts were tested, and window prophylaxis was recommended for children younger than 5 years; 80.8% of those offered prophylaxis completed the full course. [876]C Declined interventions and incomplete completion demonstrate the importance of counseling, follow-up, and monitoring adherence. [876]C
Pregnant and postpartum women and newborns may require particular attention during maternity-unit exposures because of the consequences of transmission in these populations. [876]C Diagnostic delay remains a preventable infection-control hazard: in an English national cohort of 72,039 notified TB cases from 2010–2022, 574 diagnoses were made postmortem, representing approximately 0.84% of cases. [626]B2b Social and health factors associated with postmortem diagnosis should therefore inform case-finding and referral pathways. [626]B2b
HIV, IRIS, and integrated infectious-disease prevention
TB prevention and control in people with HIV should include vigilance after antiretroviral therapy (ART) initiation. In an Italian cohort of 21 people with HIV and TB, five developed TB-associated immune reconstitution inflammatory syndrome (TB-IRIS), including two unmasking and three paradoxical cases; disseminated TB and shorter intervals between TB treatment and ART were more common among those with IRIS. [868] Radiology, histology, clinical parameters, and inflammatory markers supported diagnosis, and one paradoxical case would not have met International Network for the Study of HIV-associated IRIS criteria. [868]
Integrated screening can identify additional preventable infectious risks. In Georgia, persons with active TB underwent HBV serology and assessment of vaccination knowledge and attitudes because HBV testing was not routinely performed in TB services. [874]C Among Ukrainian pediatric refugees assessed in Switzerland, screening included infectious diseases and vaccination status; among those tested, HIV positivity was 2.7% (2/74) and hepatitis B positivity was 1.6% (2/125). [752] These refugee data and studies of TB burden in Latin America emphasize that migration, socioeconomic inequality, limited healthcare access, pathogen and host factors, and rising MDR-TB can shape regional prevention priorities. [752][853]D Finally, post-TB lung changes are clinically relevant in people with COPD because TB and its sequelae were evaluated for associations with exacerbations and mortality in a population-based cohort. [809] Prevention therefore includes both interruption of transmission and long-term follow-up of survivors with chronic respiratory disease. [809]
| Population or setting | Evidence relevant to prevention or infection control |
|---|---|
| African kidney transplant recipients | High TB burden, endemic pathogens, immunosuppression, resource constraints, and limited microbiological surveillance support context-adapted prophylaxis. [764] |
| HCWs and first responders | IGRA and TST evidence synthesized from 95 studies, 41 countries, and 63,988 participants. [232]B2a |
| Patients with IEI | Exposure history, symptoms, TST with repeat testing after 1–4 weeks when initial induration is 0–4 mm, and chest imaging were used. [783]C |
| Contacts in a maternity-unit exposure | 282 contacts were identified; 92.9% were tested; window prophylaxis was recommended for children under 5 years. [876]C |
| Children in MDR-TB-affected households | TB-CHAMP secondary analysis assessed routine immunization due by 12 months at five South African sites. [877] |
Special Hosts and Populations
- ▸Household contacts of DR-TB patients require systematic screening and individualized TPT decisions based on source-drug resistance, contact risk, and local implementation capacity. [779]
- ▸In advanced HIV disease, assess for severe or disseminated TB, including MTB bloodstream infection, and integrate screening with HIV care. [864,879,881]
- ▸Rifapentine-based TPT requires deliberate antiretroviral interaction management; review genotype history when integrase inhibitors are used. [816,851]
- ▸TBM in children and adults may deteriorate after initial treatment response; paradoxical reactions and hydrocephalus require clinical and neuroimaging follow-up. [815,836,882]
- ▸Older age, undernutrition, HIV, diabetes, smoking, alcohol use, and multimorbidity are clinically relevant risk contexts for TB mortality. [850,880]
- ▸IEI may warrant repeat TST and imaging when initial testing is negative or indeterminate. [783]
- ▸Medicine stock-outs and patient delay can undermine TB outcomes even when effective diagnostics and treatment are available. [813,780]
Household contacts of drug-resistant tuberculosis
Household contacts (HHCs) of people with drug-resistant tuberculosis (DR-TB) have increased risk of infection and progression to disease because of prolonged household exposure. Systematic screening and tuberculosis preventive treatment (TPT) are therefore central to interrupting household transmission, although screening approaches and preventive regimens vary substantially between countries and settings. [779] Contact-management programs should account for the resistance pattern of the source patient, the contact’s age and clinical risk, evidence of current disease, and the feasibility of follow-up. [779] A scoping review identified fragmented evidence, implementation barriers, and important research gaps, emphasizing that preventive-treatment decisions for contacts of DR-TB patients cannot be generalized across settings without considering local epidemiology and available regimens. [779]
A prospective South African study evaluated in-home molecular screening using tongue swabs among adult HHCs of patients with drug-sensitive pulmonary TB, comparing tongue-swab testing with sputum and assessing linkage to care. [837]C This approach is relevant for contacts who cannot readily attend clinics or provide sputum, but its diagnostic performance and programmatic value should be interpreted within the study population and local testing pathway. [837]C
People living with HIV and advanced HIV disease
Tuberculosis remains a major cause of severe illness and death among people with HIV. [864][879][881] In a multicountry prospective cohort from Malawi, South Africa, Tanzania, Thailand, Uganda, Vietnam, and Zambia, investigators assessed adults with HIV who were either hospitalized or had TB symptoms; participants had received fewer than 3 doses of anti-TB treatment in the preceding 60 days and had not received isoniazid preventive therapy during the previous 6 months. [864] The study specifically addressed Mycobacterium tuberculosis bloodstream infection (MTB-BSI), a diagnostically difficult manifestation associated with severe disease and early mortality risk. [864]
In severe HIV-associated TB, systemic bacillary load, inflammatory responses, and age interacted in relation to disease severity and mortality, supporting risk assessment that considers both pathogen burden and host characteristics. [879] Advanced HIV disease clinics may benefit from systematic screening pathways. A retrospective implementation study in Maputo, Mozambique, evaluated digital chest radiography with computer-aided detection (CAD) among new patients with advanced HIV disease; 487 patients were included and 238 underwent digital chest radiography with CAD interpretation. [881] CAD may help address shortages of trained personnel, but implementation findings remain dependent on the local screening algorithm and recorded TB diagnosis. [881]
TPT is also affected by antiretroviral drug interactions. A pharmacokinetic study of 15 adults with advanced HIV disease receiving once-daily dolutegravir-based antiretroviral therapy evaluated 1 month of daily rifapentine plus isoniazid (1HP), alongside fluconazole for cryptococcal meningitis. [816] The study was designed to characterize dolutegravir, rifapentine, and fluconazole exposure during 1HP and supports careful pharmacokinetic and clinical consideration when rifapentine-based TPT is combined with treatment for advanced HIV disease. [816] A reported case described emergent integrase-strand-transfer-inhibitor resistance after rifamycin-based LTBI treatment in a person with HIV-1, highlighting the importance of reviewing archived genotype results and avoiding unplanned antiretroviral modification during LTBI therapy. [851]C
Children and people with neurological tuberculosis
In a prospective cohort of HIV-negative children aged 6 months–14 years with newly diagnosed central nervous system TB, paradoxical reactions were defined as new or worsening lesions or symptoms after initial improvement occurring after at least 10 days of anti-TB therapy. [815]C Longitudinal clinical assessment, cerebrospinal-fluid analysis, and neuroimaging were used to document these reactions and their functional consequences at 6 months. [815]C
Tuberculous meningitis (TBM) remains a high-mortality form of TB, with reported case fatality of up to 50% in resource-limited settings. [836] A systematic review and meta-analysis of randomized and quasi-randomized trials evaluated adjunctive corticosteroids for mortality and complications including gastrointestinal bleeding, visual or auditory impairment, hydrocephalus, and joint disorders, with certainty assessed using GRADE. [836] In a lifespan cohort of non-HIV patients with TBM, hydrocephalus was evaluated as a predictor of in-hospital mortality, with analyses specifically examining whether age modified this association. [882] In Zambia, minimally invasive tissue sampling was investigated as an alternative to complete diagnostic autopsy for establishing TBM among deceased adults who had presented with meningitis, reflecting the diagnostic limitations in fatal meningitis cases. [746]C
Older adults, multimorbidity, and immune disorders
Older adults require particular attention to comorbidity, mortality risk, and diagnostic delay. A Chinese analysis of adults aged 60 years and older used Global Burden of Disease 2021 data to examine TB incidence, prevalence, mortality, disability-adjusted life-years, attributable risks, and projected trends through 2041. [850]
In a prospective South African cohort of 1,997 adults aged 15 years or older with bacteriologically confirmed pulmonary TB, investigators assessed HIV, undernutrition, diabetes, smoking, and alcohol use, as well as multimorbidity and mortality over 15 months. [880] Multimorbidity was defined as 2 or more concurrent comorbidities, and the study evaluated its association with all-cause mortality. [880]
Patients with inborn errors of immunity (IEI) may require intensified screening because both TB burden and test performance can differ from the general population. A single-center cohort of 117 patients with IEI used exposure history, symptom assessment, tuberculin skin testing, repeat testing after 1–4 weeks when the initial induration was 0–4 mm, and chest imaging when available. [783]C
Drug-resistant disease, access, and diagnostic systems
A retrospective Eritrean cohort of 257 patients treated for MDR/RR-TB from 2013–2023 examined treatment outcomes, mortality, and hematologic and biochemical predictors. [784] Preventive and therapeutic programs must also anticipate medicine shortages: a systematic review found that stock-outs of anti-TB medicines, antiretrovirals, and antimalarials remain a major challenge in low- and middle-income countries, with consequences for health-system function and patient outcomes. [813]
Patient delay is another population-level vulnerability. A meta-analysis of 42 studies involving 492,448 patients examined factors associated with TB patient delay using observational evidence and formal quality assessment. [780] Advanced statistical methods—including Bayesian, machine-learning, spatiotemporal, time-series, multistate, and survival approaches—are increasingly used in African TB research to address diagnostic uncertainty, spatial heterogeneity, and complex treatment dynamics. [801] Finally, extracellular-vesicle-associated plasma microRNAs were investigated as potential diagnostic and differential-diagnostic biomarkers for distinguishing TB from nontuberculous mycobacterial infection among patients with AIDS, but this remains an emerging biomarker approach requiring further validation. [781]C Mycobacterial species identification is also important when granulomatous tissue disease could represent TB or NTM; a South African study evaluated species distribution in formalin-fixed, paraffin-embedded tissue samples using histopathologic and mycobacterial testing. [883]
| Population | Priority considerations |
|---|---|
| HHCs of DR-TB patients | Exposure-based screening, resistance-informed TPT, and linkage to care; consider home-based molecular strategies where appropriate. [779][837]C |
| Advanced HIV disease | Screen systematically for pulmonary and disseminated TB; consider MTB-BSI and CAD-supported chest radiography where implemented. [864][879][881] |
| HIV receiving TPT | Review rifamycin–antiretroviral interactions and genotype history; monitor during 1HP. [816][851]C |
| Children with CNS TB | Monitor for paradoxical reactions after initial improvement and assess functional outcome. [815]C |
| TBM | Recognize high mortality, assess hydrocephalus, and use enhanced postmortem approaches when diagnosis remains uncertain. [836][882][746]C |
| Older or multimorbid adults | Assess HIV, undernutrition, diabetes, smoking, alcohol use, and multimorbidity as potential mortality contexts. [850][880] |
| IEI | Combine exposure history, symptoms, TST, repeat testing when initially 0–4 mm, and imaging. [783]C |
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