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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 caused by Mtb within the MTBC; MTBC also contains human- and animal-associated strains. [917][922]
- ▸NTM, including MAC, are distinct from MTBC and may mimic pulmonary or extrapulmonary TB. [908][919]
- ▸Classify TB by infection state as LTBI or active disease, by anatomy as pulmonary or extrapulmonary, and by drug susceptibility as drug-susceptible TB or DR-TB, including MDR-TB. [909][918][920]
- ▸TBM, STB, and tuberculous subretinal abscess are extrapulmonary forms documented in the cited evidence. [904][910][911]
- ▸BCG is an experimental surrogate for virulent Mtb, not a usual cause of human TB. [914]
Definition
Tuberculosis (TB) is an infectious disease caused by members of the Mycobacterium tuberculosis complex (MTBC), with Mycobacterium tuberculosis (Mtb) representing the principal human pathogen described in the available evidence. [917]D[919]D The MTBC encompasses genetically and epidemiologically distinct human- and animal-associated strains; experimental work has examined both human and animal MTBC strains and demonstrated strain-dependent host responses in human and bovine macrophage models. [922]D Evidence from a One Health investigation also supports the importance of considering MTBC infection at animal–human interfaces, including camel populations and exposed abattoir workers. [891]
TB should be distinguished from infection caused by nontuberculous mycobacteria (NTM). NTM, including organisms within the Mycobacterium avium complex (MAC), may produce overlapping pulmonary or extrapulmonary clinical presentations and can therefore be misclassified as TB without organism-specific testing. [908][919]D A positive mycobacterial result is consequently insufficient by itself to establish TB unless the organism is assigned to MTBC or otherwise demonstrated to be Mtb. Molecular assays may differentiate MTBC from MAC by targeting distinct genetic markers, including IS6110 for MTBC and rrs targets for MAC. [919]D
Classification by infection state
The major clinical distinction is between latent tuberculosis infection (LTBI) and active TB disease. LTBI is represented in the cited evidence by children with immunologically recognized Mtb infection without the disease phenotype under study, whereas active TB includes clinically manifest pulmonary or extrapulmonary disease. [920]D Progression from LTBI to active disease is particularly important in children and may be facilitated by HIV-associated immune dysfunction. [920]D HIV infection with concomitant Mtb infection is also associated with marked alterations in Toll-like- and chemokine-receptor expression, especially in advanced HIV infection. [916]D
Active TB may be classified anatomically as pulmonary TB or extrapulmonary TB. Pulmonary disease is the principal setting addressed by sputum microscopy, stool-based molecular testing in children, and assays designed to distinguish MTBC from MAC and other pathogens. [905][919]D[921]D Extrapulmonary TB includes disease of the central nervous system, spine, eye, and other organs. Tuberculous meningitis (TBM) is a severe extrapulmonary form with potential for encephalitic involvement, neurological sequelae, and death, particularly when diagnosis is delayed in children. [907][911]C Spinal tuberculosis (STB), also termed tuberculous spondylitis in the cited literature, is another extrapulmonary manifestation and may resemble pyogenic or brucellar spondylitis clinically and radiologically. [904]C Tuberculous subretinal abscess is an ocular manifestation that can be distinguished from non-tuberculous subretinal abscess using clinical and microbiological evidence. [910]C
Classification by drug resistance
Active TB is also classified according to antimicrobial susceptibility. Drug-resistant TB (DR-TB) comprises disease caused by Mtb or other MTBC organisms with clinically relevant resistance; multidrug-resistant TB (MDR-TB) is specifically identified in the cited paediatric pharmacokinetic literature as a treatment category requiring optimized fluoroquinolone exposure. [909][918]D This classification is clinically separate from anatomical classification: pulmonary or extrapulmonary TB may be drug-susceptible or drug-resistant. Mortality remains substantial among patients with DR-TB, and survival-based prognostic factors have been evaluated across forms of DR-TB. [909]
Causative organisms and important exclusions
The causative organism for conventional human TB is Mtb within the MTBC. [917]D[919]D BCG is an attenuated mycobacterial vaccine strain and was used as a biosafety surrogate for virulent Mtb in an experimental tuberculous-granuloma model; its use in that model should not be interpreted as evidence that BCG is a usual cause of human TB. [914]D NTM are separate from MTBC and include MAC organisms capable of pulmonary infection; immune responses to MAC glycopeptidolipids have been investigated in patients with pulmonary NTM disease and compared with patients with TB. [908]
Other organisms may produce syndromes that mimic TB and should remain in the differential diagnosis. In spinal infection, pyogenic bacteria and Brucella species may resemble STB. [904]C Cutibacterium modestum can cause post-vertebroplasty spondylodiscitis with vertebral destruction, disc-space involvement, paravertebral extension, and psoas abscess-like collections that mimic tuberculous spondylitis. [912]C Burkholderia pseudomallei can also overlap clinically with TB and NTM disease and is detectable in multiplex assays designed to distinguish it from MTBC and MAC. [919]D These mimics are not causative organisms of TB and require organism-specific confirmation.
Practical classification summary
For clinical and reference purposes, TB should therefore be described using three complementary axes: infection state (LTBI or active disease), anatomic distribution (pulmonary or extrapulmonary, including TBM, STB, and ocular disease), and drug susceptibility (drug-susceptible TB or DR-TB, including MDR-TB). [904]C[909][910]C[911]C[918]D[920]D The etiological assignment should then confirm MTBC/Mtb and exclude NTM and non-mycobacterial mimics when the clinical presentation overlaps. [908][912]C[919]D
| Classification axis | Categories or examples | Supporting evidence |
|---|---|---|
| Infection state | LTBI; active TB disease | [916]D[920]D |
| Anatomic site | Pulmonary; extrapulmonary, including TBM, STB, and ocular disease | [904]C[905][910]C[911]C |
| Drug susceptibility | Drug-susceptible TB; DR-TB; MDR-TB | [909][918]D |
| Etiology | MTBC/Mtb; distinguish from NTM such as MAC | [908][917]D[919]D |
Microbiology and Pathogenesis
- ▸Mtb pathogenesis reflects bacterial adaptation, host immunity, tissue microenvironments, and treatment-related selection rather than a single mechanism. [942][949][954]
- ▸Macrophage state, diabetes-associated metabolic dysfunction, granuloma heterogeneity, and immune-cell remodeling strongly influence bacterial persistence and tissue injury. [789][890][948][950]
- ▸Mtb immune evasion includes suppression of cGAS–STING/type-I-interferon signalling, epigenetic modulation, altered vesicle communication, and immunometabolic regulation. [917][951][952][953]
- ▸Drug-resistant tuberculosis remains a major global challenge: approximately 390,000 MDR/RR-TB cases occurred in 2024, with only 42% treatment coverage. [942]
- ▸Tuberculosis may be microbiologically or clinically silent, and advanced molecular testing such as third-generation sequencing is promising but still under evaluation for extrapulmonary disease. [884][944]
Microbiological basis
Tuberculosis is caused predominantly by Mycobacterium tuberculosis (Mtb), a member of the M. tuberculosis complex (MTBC). Current research conceptualizes disease as the result of interacting bacterial, host, tissue, and treatment-level processes rather than of bacterial replication alone. These processes include resistance-associated mutations, bacterial adaptation to host-imposed stress, host–pathogen interactions, and drug–target effects. [942] Mtb also depends on metabolic flexibility during infection; amino-acid biosynthesis and transport support proliferation and contribute precursors for cell-wall lipid components, including acetyl-CoA- and propionyl-CoA-derived products. [947]D
Mtb adapts its transcriptional state to anatomically and immunologically distinct host niches. Genome-wide profiling in rabbit lungs with active tuberculosis—an experimental setting that reproduces important features of human disease, including granuloma heterogeneity, necrosis, and cavitation—identified extensive context-dependent bacterial transcriptional reprogramming compared with broth culture. [954]D These observations support a model in which nutrient limitation, hypoxia, inflammatory stress, cellular damage, and changing granuloma microenvironments select distinct bacterial states. [949]D[954]D
Cellular and tissue pathogenesis
Macrophages are primary host cells targeted by Mtb and coordinate pathogen recognition, phagocytosis, antigen presentation, intracellular killing, granuloma organization, and disease progression. [789][948]D Macrophage behavior is context dependent: pro-inflammatory, microbicidal M1-like programs may restrict bacterial growth, whereas anti-inflammatory and tissue-reparative M2-like programs can promote persistence or alter tissue injury when insufficiently coupled to antimicrobial activity. [948]D Hyperglycaemia further disrupts this balance; in individuals with tuberculosis and type 2 diabetes, metabolic dysregulation is associated with altered macrophage phenotype, reduced antimicrobial responses, and impaired intracellular bacterial clearance, with CD206 implicated in this process. [789]
Granulomas are dynamic structures rather than uniformly protective lesions. Their cellular composition, inflammatory intensity, necrosis, and vascular or oxygen environment generate heterogeneous niches that shape bacterial replication, persistence, host damage, and antimicrobial exposure. [948]D[949]D[954]D Within-host models increasingly integrate molecular, cellular, tissue, and systemic scales, including immune regulation, granuloma biology, pharmacokinetics, pharmacodynamics, and treatment response. [949]D
Adaptive and innate immune responses both influence outcome. NK-cell number, subset distribution, and function change during tuberculosis, with reported depletion associated with disease progression; NK cells contribute to early antimicrobial activity and can activate adaptive immune responses. [950]D CD4+CD8+ double-positive T cells have also been associated with tuberculosis susceptibility, disease severity, and treatment-related outcomes, although their mechanistic role remains under investigation. [890] In tuberculous meningitis, exploratory multi-omics work has linked altered gut microbiota and microbial metabolites with host gene-expression and immune-infiltration patterns; the proposed microbiota–metabolite–gene axis remains preliminary because it was derived from a small cohort of 11 patients and 11 controls with in-vitro validation. [907]
Immune evasion and host–pathogen signalling
Mtb can modify host innate signalling to promote intracellular survival. The bacterial protein Rv0158 was identified through genome-wide loss-of-function screening as a negative regulator of the cGAS–STING pathway; loss of this function increased IFN-β and selected pro-inflammatory cytokines, whereas Rv0158 activity was associated with suppression of type-I-interferon responses and enhanced intracellular survival. [951]D Mtb-associated epigenetic and metabolic effects also influence host defence, including pathways involving histone acetylation, DNA methylation, non-coding RNAs, autophagy, oxidative stress, lipid metabolism, and efflux mechanisms. The mycobacterial DNA methyltransferase Rv2966c has been reported to modify host histones H3 and H4, although the broader translational significance of these findings remains under study. [952]D
Extracellular vesicles, including exosomes released by infected mammalian cells, may act as a double-edged communication system. They can transport host- and pathogen-derived proteins, lipids, DNA, microRNAs, and circular RNAs, potentially supporting antimicrobial communication while also contributing to immune dysregulation and disease progression. [917]D The oxysterol-sensing receptor GPR183/EBI2 is another immunometabolic regulator of interest; its activity is shaped by oxysterol gradients, particularly 7α,25-dihydroxycholesterol, and is being investigated as a possible host-directed therapeutic target. [953]D
Strain variation, resistance, and diagnosis
MTBC lineages differ in geographic distribution and apparent host compatibility. In macrophage models using human THP-1-derived and bovine cells, infection frequency, intracellular bacterial burden, cell death, and host transcriptional responses varied according to the combination of host model and MTBC strain, supporting lineage-specific adaptation across host species. [922]D Drug resistance reflects resistance-associated mutations, altered drug targets, bacterial adaptation, and host–pathogen interactions; approximately 390,000 people developed multidrug- or rifampicin-resistant tuberculosis in 2024, while treatment coverage was only 42%, according to a recent global research review. [942]
Microbiological confirmation remains difficult in paucibacillary or extrapulmonary disease. Tuberculous pericarditis is a severe, high-mortality manifestation in which invasive sampling and limited sensitivity of conventional tests constrain diagnosis; third-generation sequencing is being evaluated as a rapid, broad molecular approach, but its diagnostic accuracy is not yet established because the cited work is a systematic-review protocol. [884] In children evaluated for pulmonary tuberculosis, induced sputum tested by liquid culture and Xpert Ultra has been used for microbiological classification. [945] Active screening studies also demonstrate that a substantial proportion of pulmonary tuberculosis can be clinically silent: 56.5% of cases in one Italian high-risk cohort were asymptomatic, compared with 43.5% symptomatic cases. [944] HIV–Mtb coinfection may further amplify systemic complications, including ischemic stroke risk, but the precise biological mechanisms and treatment interactions remain unresolved. [946]D
| Level | Mechanism or determinant | Reported implication |
|---|---|---|
| Bacterial metabolism | Amino-acid uptake and biosynthesis | Supports Mtb proliferation and cell-wall lipid precursor production. [947]D |
| Bacterial adaptation | Context-dependent transcription in lung niches | Enables adaptation to heterogeneous granuloma, necrotic, and cavitary environments. [954]D |
| Macrophage biology | M1-like versus M2-like functional states | Alters intracellular killing, inflammation, tissue repair, and granuloma outcomes. [789][948]D |
| Innate signalling | Rv0158 regulation of cGAS–STING | Suppresses type-I-interferon responses and enhances intracellular survival. [951]D |
| Host metabolism | Hyperglycaemia and CD206-associated dysfunction | Impairs macrophage antimicrobial responses and bacterial clearance. [789] |
| Immune regulation | NK cells, double-positive T cells, and GPR183/EBI2 | Modifies antimicrobial immunity, severity, and potential host-directed treatment strategies. [890][950]D[953]D |
| Population biology | MTBC lineage–host compatibility | Produces strain- and host-specific infection and transcriptional phenotypes. [922]D |
| Antimicrobial resistance | Mutations, adaptation, and drug-target mechanisms | Drives MDR/RR-TB and limits treatment effectiveness. [942] |
Epidemiology, Transmission and Risk Factors
- ▸TB epidemiology varies by setting, and notification rates reflect both disease burden and the ability of health systems to detect and report cases [931,937,938].
- ▸Children and adolescents younger than 18 years have a higher risk of progression from TB infection to disease than adults, making contact investigation and preventive treatment priorities [923].
- ▸Household exposure is a central risk context for childhood TB, particularly in marginalised communities; BCG protection and programme delivery vary by setting [936].
- ▸Men have higher TB incidence than women globally, and sex differences may reflect both infection risk and progression after infection [927].
- ▸HIV, older age, migration, imprisonment, informal mining, smoking, poverty and childhood are important overlapping vulnerability contexts [932,934,935,940,941].
- ▸TPT uptake and timing among people living with HIV, and the duration of protection after TPT, are key determinants of preventive effectiveness [924,934].
- ▸Animal–human interfaces and immune-checkpoint inhibitor treatment warrant targeted vigilance, but available studies do not prove routine zoonotic transmission or causality [891,930].
Global epidemiology and distribution
Tuberculosis (TB) remains epidemiologically heterogeneous, with marked differences in transmission, disease incidence, drug resistance and HIV-associated disease between regions. Long-term modelling of Global Burden of Disease Study 2023 data in China assessed TB incidence, prevalence, mortality and disability-adjusted life-years from 1990–2023, with specific attention to HIV-negative TB, drug-susceptible TB, multidrug-resistant TB and extensively drug-resistant TB; the study also projected future patterns, underscoring the continuing importance of surveillance despite substantial national progress [937]. In southern Xinjiang, a rural health-examination campaign tested 3,742 adults across 22 villages and farm units in July–August 2024 to examine whether village-level TB notification rates predicted interferon-γ release assay (IGRA) positivity, using the preceding notification rate as the principal exposure [938]. These data illustrate that local transmission intensity can vary substantially within a country and that pre-screening notification rates may help identify communities with greater latent infection burden [938].
A population-level quasi-experimental study in Viet Nam evaluated an intermediary-facilitated public–private mix intervention designed to connect private and other out-of-network providers with the national TB programme and improve case notification in a fragmented health system [931]. Such interventions address ascertainment and treatment-coverage gaps, but notification data should not be interpreted as a direct measure of transmission because they are influenced by access to care, diagnostic capacity and reporting practices [931].
Transmission and progression from infection to disease
Mycobacterium tuberculosis transmission is most strongly reflected epidemiologically by infection among contacts and by geographic variation in infection prevalence. The available preventive-treatment evidence specifically concerns children and adolescents younger than 18 years with TB infection or exposure to drug-susceptible TB, without HIV; this population is recognized as having a higher risk of progression to disease than adults [923]. A systematic review and individual-participant meta-analysis evaluated the duration of protection from TB preventive treatment (TPT) among close contacts and people with evidence of M. tuberculosis infection across high-, medium- and low-burden settings, addressing whether protection varies according to the background risk of reinfection or disease [924].
Household exposure is a major childhood risk context. A community-based case–control study in rural Bangladesh enrolled children aged 2–14 years and examined household TB exposure and BCG vaccination in relation to newly diagnosed confirmed childhood TB, with community-matched controls recruited from the same neighbourhoods [936]. The study focused on tea-garden worker communities, highlighting the relevance of socially marginalised and resource-limited populations to childhood transmission and prevention [936]. BCG and household exposure should therefore be considered together when assessing a child’s risk, while local delivery and effectiveness may vary between communities [936].
Demographic and biological risk factors
Sex differences are consistent across settings: TB incidence is generally higher in men than women globally [927]. A pooled individual-participant analysis of 11 prospective cohorts involving 22,424 participants from sub-Saharan Africa, Europe, Asia and South America examined whether this difference reflected greater infection risk, sex-specific progression from infection to disease, or both. Infection was defined using a positive QuantiFERON-TB Gold In-Tube result, and incident TB included bacteriologically confirmed or clinically diagnosed disease; models adjusted for age and used mixed-effects logistic and Cox regression [927].
HIV remains an important determinant of TB risk and disease burden. A prevalence-survey analysis from Zambia and South Africa used 2019–2021 data from 21 communities to estimate the excess TB prevalence among people living with HIV who were receiving antiretroviral therapy (ART), compared with their counterfactual HIV-negative state [940]. ART reduces TB incidence, but TB remains a leading cause of morbidity and mortality in people living with HIV, and the effect of ART on population TB prevalence may be less complete [940]. In South Africa, clinic data from 36 public-sector clinics covering 2005–2022 assessed whether people initiating ART received TPT within ≤6 months, after >6 months, or not at all, demonstrating that timing and uptake of preventive therapy are important components of HIV-associated TB prevention [934].
Older age is particularly relevant to drug-resistant TB. A Chinese retrospective cohort included 667 patients aged ≥65 years with multidrug- or rifampicin-resistant TB treated during 2010–2022 and examined attrition across diagnosis, treatment initiation and subsequent retention stages [932]. Advanced age may therefore compound risk through delayed diagnosis, comorbidity, treatment complexity and loss from the care cascade [932]. In Shenzhen, a nine-year retrospective study of 16,466 TB patients from 2017–2025 evaluated demographic and clinical predictors of drug-resistant TB in a rapidly developing city with a large migrant population [935]. Migration and population mobility are consequently relevant epidemiological considerations when interpreting resistance patterns and ensuring continuity of care [935].
Vulnerable populations and special exposures
A Ghanaian cross-sectional study conducted in September–November 2024 evaluated recurrent TB among 436 people from key vulnerable groups, including people living with HIV, informal miners, prisoners, rural-poor communities, smokers and children [941]. These groups represent overlapping social, occupational and clinical risks for exposure, delayed diagnosis, reinfection or recurrence [941].
Potential zoonotic or occupational interfaces also require attention. In Abu Dhabi, a One Health investigation screened 356 farm camels, 393 slaughter camels and 86 abattoir workers for TB-complex antibody reactivity; reactivity was detected in 33/356 field camels (9.3%; 95% CI 6.5%–12.8%), and two reactive slaughtered camels had lesions investigated by histopathology, Ziehl–Neelsen staining and IS6110 PCR [891]. These findings support investigation of animal–human interfaces but do not establish routine camel-to-human transmission [891].
Cancer treatment may modify risk through immune alteration. A real-world study followed 889 cancer patients receiving immune-checkpoint inhibitors in Shenzhen from 2018–2024 and evaluated active TB occurring after treatment initiation [930]C. Immune-checkpoint inhibitor exposure should therefore prompt awareness of TB in high-burden settings, although this retrospective design cannot establish causality or quantify risk for all treated patients [930]C.
Interpretation and evidence boundaries
Extrapulmonary TB is epidemiologically important but may have different risk profiles from pulmonary disease. An eight-year retrospective study in Fuyang, China, characterized extrapulmonary TB from 2018–2025, including temporal patterns, diagnostic yields of IGRA, Xpert MTB/RIF Ultra and culture, and drug resistance [933]. Conversely, studies of TB-associated dyslipidaemia [925] and prediction of anti-TB drug-induced liver injury [926][929] address treatment-related or metabolic outcomes rather than acquisition or transmission risk; they should not be used as independent evidence that lipid abnormalities or liver-injury predictors cause TB. The preventive-treatment literature emphasizes that children and adolescents require particular protection because progression after infection is more likely, while the duration of TPT protection may differ across epidemiological settings [923][924].
| Risk context | Evidence and relevance |
|---|---|
| Childhood and household exposure | Children under 18 years have greater progression risk; household exposure was assessed in Bangladeshi children aged 2–14 years [923][936]. |
| HIV | TB remains a major cause of morbidity and mortality despite ART; TPT uptake and timing remain important [934][940]. |
| Sex | TB incidence is globally higher in men; pooled cohorts assessed infection and progression mechanisms [927]. |
| Older age and drug resistance | Chinese data included patients aged ≥65 years with MDR/RR-TB and evaluated care-cascade attrition [932]. |
| Mobility and vulnerable occupations | Migrant populations, informal miners, prisoners, smokers and rural-poor communities may experience overlapping exposure and access risks [935][941]. |
| Special interfaces | Camel–human exposure and immune-checkpoint inhibitor treatment represent settings requiring additional clinical awareness [891][930]C. |
Clinical Presentation
- ▸Pulmonary TB commonly overlaps clinically with pneumonia and aspergillosis; cough, fever, and dyspnea are not specific. [965]
- ▸Paucibacillary pulmonary TB may be smear-negative because bacillary loads fall below conventional detection thresholds. [955]
- ▸In spinal TB, back or neck pain was reported in 89% of patients, and thoracic involvement occurred in 66% in a three-hospital London study. [956]
- ▸Pediatric TB is often nonspecific and microbiologically unconfirmed; bacteriological confirmation was reported in 37.5% of 48 Romanian pediatric cases. [958]
- ▸Tuberculous meningitis in children may progress from meningeal inflammation to encephalitis and irreversible neurological injury when recognition is delayed. [911]
- ▸In people living with HIV, fever of unknown origin and unexplained cytopenias may prompt evaluation for marrow-associated infectious, neoplastic, or inflammatory disease. [928]
Overview
Tuberculosis (TB) has a highly variable clinical presentation, reflecting the involved organ, bacillary burden, host immune status, and age. Pulmonary TB may resemble other respiratory infections because cough, fever, and shortness of breath also occur with pneumonia and aspergillosis, creating a risk of delayed or incorrect recognition. [965]D Clinical overlap is particularly important when distinguishing spinal TB from pyogenic and brucellar spondylitis, because the three conditions may present with similar symptoms and routine findings. [904]C
Pulmonary tuberculosis
Adults with paucibacillary pulmonary TB may have smear-negative disease, in which the number of organisms is below the detection threshold of conventional microbiological testing. [955]C In this setting, clinical suspicion may persist despite negative initial testing, and diagnosis often requires integration of molecular assays with host-response testing. [955]C A prospective study specifically evaluated adults with suspected smear-negative pulmonary TB using GeneXpert MTB/RIF, TB-DNA PCR, and T-SPOT.TB, underscoring the diagnostic difficulty of clinically suspected disease with limited bacillary load. [955]C
Respiratory symptoms can be nonspecific. Cough, fever, and dyspnea are shared by TB, pneumonia, and aspergillosis, and this overlap may delay appropriate treatment. [965]D Tracheobronchial TB may be especially deceptive: a young man presented with acute cough, chest tightness, and fever, while computed tomography showed an obstructive endobronchial mass initially interpreted as an airway tumor. [962]C Severe airway obstruction in this form may require urgent bronchoscopic assessment, and airway stenosis is a recognized risk. [962]C
Clinical severity and later structural consequences may not be apparent from symptoms alone. In a prospective cohort of 38 adults with newly diagnosed, microbiologically confirmed, drug-susceptible pulmonary TB, baseline clinical and laboratory factors were assessed before treatment and structural lung damage was evaluated after the 2-month intensive phase. [963] The study was designed to identify predictors of early radiographic damage, emphasizing that clinically important lung injury can be present or develop during treatment even when patients are receiving therapy. [963]
Pediatric tuberculosis
Children frequently have nonspecific disease and may lack microbiological confirmation. [958] In a Romanian tertiary hospital cohort of 48 children, the median age was 14 years (interquartile range, 8.25–16 years), and 37.5% were bacteriologically confirmed. [958] Pediatric TB therefore requires consideration even when symptoms, imaging, or routine investigations do not provide definitive microbiological evidence. [958]
The diagnostic challenge is compounded by the limited sensitivity of available tests and the invasiveness of some sampling methods. [905] The World Health Organization endorsed stool-based molecular testing as an initial diagnostic approach for pediatric TB in 2021, and a multicentre prospective study evaluated centrifugation-free stool processing with Xpert MTB/RIF Ultra in children younger than 15 years across South Africa, Tanzania, Malawi, Mozambique, and India. [905]
Spinal tuberculosis
Back or neck pain is the dominant presenting symptom of spinal TB. In a retrospective study from three London hospitals, 55 of 62 patients (89%) presented with back or neck pain; 45 of 62 (73%) were male, 52 of 62 (84%) were migrants, and the median age was 33 years (interquartile range, 26–40 years). [956]C The thoracic spine was most frequently involved, affecting 41 of 62 patients (66%). [956]C These findings support spinal TB as an important consideration in persistent axial pain, particularly when epidemiological risk or compatible imaging is present. [956]C
Preoperative differentiation from pyogenic and brucellar spondylitis is difficult because the clinical phenotypes overlap. [904]C Culture turnaround time may delay classification, while serological testing for brucellosis may not be readily available. [904]C Brucellosis remains a relevant alternative diagnosis in patients with spinal inflammatory disease, and ongoing work has focused on improving serological specificity because cross-reactivity with lipopolysaccharide antigens can limit current assays. [957]C
Tuberculosis in people living with HIV
In people living with HIV, TB may present as part of a broader syndrome of advanced immunosuppression. Bone marrow abnormalities in this population may reflect infectious, neoplastic, or inflammatory disease, particularly when patients have fever of unknown origin or unexplained cytopenias. [928]C Bone marrow evaluation was studied in adults with HIV at a Venezuelan tertiary referral center because these presentations can be diagnostically complex. [928]C
Tuberculous meningitis and disseminated disease
Tuberculous meningitis is a severe extrapulmonary form of TB in children and may be difficult to recognize during its early clinical phase. [911]C Delayed recognition of meningeal inflammation can be followed by cerebral parenchymal involvement, including encephalitis, with potentially irreversible neurological sequelae. [911]C Clinicians should therefore treat persistent or progressive neurological manifestations in a child with epidemiological or systemic evidence of TB as potentially urgent. [911]C
Disseminated or extrapulmonary presentations may include involvement of multiple serosal compartments, although similar syndromes can also be caused by nontuberculous mycobacteria. [961]C For example, an 83-year-old man developed intermittent fever approximately 6 weeks after coronary stenting, with new pericardial adhesion and early constrictive physiology; subsequent evaluation identified suspected Mycobacterium abscessus-associated polyserositis rather than established TB. [961]C This illustrates the importance of distinguishing TB from nontuberculous mycobacterial disease when fever and multisystem or serosal manifestations dominate the presentation. [908][961]C
Clinical interpretation
No single symptom reliably distinguishes TB from its infectious mimics. [904]C[965]D The presentation should be interpreted alongside age, immune status, epidemiological context, anatomical site, imaging, and microbiological or immunological testing, recognizing that paucibacillary disease and pediatric disease may remain microbiologically unconfirmed. [905][928]C[955]C[958]
Diagnosis and Workup
- ▸Use a multimodal diagnostic strategy combining representative sampling, culture, molecular testing, histopathology, imaging, and clinical adjudication. [888][895][898][899]
- ▸Interpret Xpert MTB/RIF Ultra according to specimen type and reference standard; Probe C reactivity can cross-react with some Nocardia species. [892][898]
- ▸mNGS may help in culture-negative or culture-confounded osteoarticular and spinal infection, but should be interpreted with clinical, radiological, and histopathological evidence. [888][899]
- ▸TGS for tuberculous pericarditis remains investigational because the cited evidence is a systematic-review protocol, not a completed accuracy study. [884]
- ▸T-SPOT.TB and QuantiFERON-TB Gold Plus are not fully interchangeable, particularly for indeterminate results; sequential testing should be individualized. [886]
- ▸Host antibody, transcriptomic, genetic, and double-positive T-cell biomarkers are promising for severity stratification or future diagnosis but are not established replacements for microbiological confirmation. [885][889][890]
- ▸In children unable to provide sputum, stool molecular testing is a non-invasive option, while stool mNGS remains under evaluation. [901]
- ▸Post-tuberculosis imaging abnormalities and HIV-associated TB-IRIS should be distinguished from active tuberculosis and treatment failure. [887][893][894]
Diagnostic approach
Diagnosis should be integrated across clinical presentation, imaging, microbiology, histopathology, and—when conventional testing is unrevealing—validated molecular methods. The available evidence supports a multimodal approach because diagnostic performance varies by disease site, specimen type, reference standard, prior antimicrobial exposure, and the presence of alternative pathogens. [888][895][898][899]C
Initial assessment should define the suspected anatomical site and obtain the most representative, least contaminated specimen possible. In spinal or osteoarticular disease, conventional cultures may be negative or confounded by recovery of non-mycobacterial organisms, and tissue sampling remains important for microbiological and histopathological confirmation. [895][899]C In suspected spondylodiscitis, image-guided biopsy has been evaluated using both computed tomography and fluoroscopic guidance, with biopsy yield and the effect of pre-biopsy empiric antibiotics being clinically relevant considerations. [895] In confirmed tuberculous osteoarticular infection, mNGS was specifically investigated in patients with negative or misleading conventional cultures, using mNGS positivity combined with histopathological or clinical validation as a composite reference standard. [899]C
Microbiological and molecular testing
Culture remains an important reference method in evaluations of molecular assays, but its limitations are particularly relevant in paucibacillary or extrapulmonary disease. [884][898][899]C Xpert MTB/RIF Ultra has been assessed against both mycobacterial culture and a composite reference standard in adults in an intermediate-tuberculosis-burden setting, with performance reported for tuberculosis detection and rifampicin resistance. [898] Results should therefore be interpreted in the context of the reference standard and specimen type rather than as a universal sensitivity estimate. [898]
A positive molecular result should also be reviewed for potential assay-specific pitfalls. GeneXpert MTB/RIF Probe C showed species-specific cross-reactivity with some Nocardia isolates in a large retrospective analysis of 14,141 non-duplicate clinical samples; the phenomenon was evaluated against Nocardia culture results and by comparing the probe target region with genomes from 1,082 Nocardia strains. [892] Thus, an unexpected or discordant MTB/RIF result—particularly when clinical, radiological, and culture findings suggest nocardiosis—may require confirmatory testing and consideration of alternative organisms. [892]
Metagenomic next-generation sequencing can provide unbiased pathogen detection and may be useful when conventional cultures are negative, confounded, or obtained after antimicrobial exposure. [888][899]C In spinal infection, a retrospective study of 208 patients incorporated mNGS into a multimodal framework that combined clinical, radiological, microbiological, and histopathological information; the study examined not only organism identification but also the incremental clinical value of integrated prediction. [888] In tuberculous osteoarticular infection, mNGS was evaluated in 13 confirmed cases, including culture-negative and culture-confounded infections, and was used alongside histopathological or clinical validation rather than as an isolated diagnostic endpoint. [899]C
For children with presumptive pulmonary tuberculosis, stool-based molecular testing offers a non-invasive alternative when sputum is difficult to obtain, although stool testing has generally been less sensitive than sputum-based testing. [901]D Shotgun stool mNGS was evaluated in Ugandan children against both a microbiological reference standard—defined by positive sputum Xpert Ultra or culture—and a composite reference standard that also included unconfirmed tuberculosis; its performance was compared with stool Xpert Ultra, and enriched genomic loci were investigated as potential targets for future assays. [901]D
Third-generation sequencing is a promising approach for tuberculous pericarditis because specimen collection is invasive and conventional microbiological tests have limited sensitivity, but the cited publication is a systematic-review and meta-analysis protocol rather than a completed accuracy study. [884] Consequently, TGS should be considered investigational for tuberculous pericarditis until pooled diagnostic estimates and clinical validation are available. [884]
Immune-based and host-response tests
Interferon-γ release assays should be interpreted as tests of tuberculosis infection rather than standalone proof of active disease. A prospective study of 703 people undergoing concurrent T-SPOT.TB and QuantiFERON-TB Gold Plus testing compared results across microbiologically confirmed tuberculosis, presumed infection treated preventively, and culture-confirmed nontuberculous mycobacterial disease; it also examined indeterminate results using interferon-γ responses and host immune factors. [886] The study found clinically relevant differences between the two assays, including differences in positivity and indeterminate-result patterns, supporting assay-specific interpretation and selective sequential testing rather than assuming interchangeability. [886]
Circulating antibody signatures against ESAT-6/CFP-10, Ag85A, HspX, and Rv2626c were studied in patients with active tuberculosis alongside clinical, radiological, and laboratory variables. [885] Factor Analysis of Mixed Data identified systemic and pulmonary severity components that were combined into an overall severity score, while antigen-specific IgG responses were evaluated for associations with severe and mild disease. [885] These signatures may support future disease-severity stratification, but the cited evidence does not establish them as replacement tests for microbiological diagnosis. [885]
Other proposed host biomarkers remain exploratory. Integrated multi-omics analyses identified MARCO and ZBTB20 as candidate shared biomarkers in rheumatoid arthritis and tuberculosis, using transcriptomic datasets, differential-expression analysis, co-expression networks, LASSO selection, and external or single-cell datasets. [889] Genetic and immunological analyses have also examined CD4+CD8+ double-positive T cells in relation to tuberculosis susceptibility, severity, and treatment outcomes, including a genome-wide association analysis of 731 immune-cell traits and a tuberculosis dataset of 895 patients. [890] These findings require clinical validation before routine diagnostic use. [889][890]
Imaging and special diagnostic contexts
Imaging should be interpreted with microbiological and clinical data because tuberculosis-related abnormalities may overlap with malignancy, bacterial infection, inflammatory disease, or post-tuberculosis sequelae. [888][893]C[894] In lung-cancer screening, a Korean Lung-RADS category 2b was introduced for nodules considered likely benign, including tuberculous granulomas or intrapulmonary lymph nodes, and was evaluated in 1,371 screening participants with attention to diagnostic performance and interreader agreement. [894] Prior pulmonary tuberculosis may also be followed by fibrotic scarring, bronchiectasis, volume loss, or a progressive fibrotic interstitial-lung-disease phenotype on serial high-resolution CT; these findings should not automatically be interpreted as active tuberculosis. [893]C
In people living with HIV, new or worsening findings after antiretroviral initiation require consideration of tuberculosis-associated immune-reconstitution inflammatory syndrome. In a 15-year retrospective cohort, 28/123 (22.8%) patients developed TB-IRIS, including paradoxical disease in 18/89 (20.2%) at risk and unmasking disease in 10/34 (29.4%) at risk; lymph nodes and the central nervous system were among frequently involved sites. [887]C TB-IRIS is a clinical diagnosis of exclusion and should prompt reassessment for active tuberculosis, treatment failure, drug resistance, alternative infection, and other inflammatory causes. [887]C
| Modality or context | Main use | Important limitation or interpretation |
|---|---|---|
| Culture and histopathology | Confirmation of tuberculosis, especially in tissue-based disease | May be negative or confounded in paucibacillary, osteoarticular, spinal, or previously treated disease. [895][899]C |
| Xpert MTB/RIF Ultra | Rapid molecular detection and rifampicin-resistance assessment | Performance depends on specimen and reference standard; intermediate-burden data have been specifically evaluated. [898] |
| GeneXpert Probe C | Molecular MTB assay target | Cross-reactivity with some Nocardia isolates can produce discordant findings. [892] |
| mNGS | Unbiased pathogen detection in difficult or culture-negative infections | Requires clinical, radiological, histopathological, or composite-standard validation. [888][899]C |
| T-SPOT.TB and QFT-GP | Evidence of tuberculosis infection | Assays differ in positivity and indeterminate-result patterns; neither alone establishes active disease. [886] |
| Stool mNGS or stool Xpert Ultra | Non-invasive pediatric testing | Evaluated against microbiological and composite standards; generally less sensitive than sputum-based testing. [901]D |
| TGS for tuberculous pericarditis | Potential future molecular test | Diagnostic accuracy is not yet established in the cited protocol. [884] |
Severity Assessment and Risk Stratification
- ▸Assess TB severity across physiology, disease distribution, neurological status, pathogen burden, host vulnerability, inflammation, treatment resistance, and long-term functional risk. [885][879][801]
- ▸Disseminated TB, CNS-TB, HIV-associated TB, paraplegia or cord compression, and drug-resistant TB identify particularly high-risk clinical phenotypes. [969][967][879][804][909]
- ▸Use prediction models only after evaluating population applicability, discrimination, calibration, and external validation; no single universal TB severity score is established by the supplied evidence. [926][801]
- ▸Immune signatures, lymphocyte subsets, and circulating antibodies are promising adjuncts but lack validated universal bedside thresholds. [885][890][969]
- ▸Severity must be reassessed dynamically because clinical, microbiological, radiological, and treatment-response data evolve over time. [885][801]
Scope and principles
Tuberculosis severity should be assessed as a multidimensional construct rather than inferred from a single symptom, radiographic finding, or laboratory value. Current evidence supports integrating clinical phenotype, organ involvement, pathogen burden, host vulnerability, inflammatory response, treatment-related risk, and anticipated outcomes. [885][879][801] Most available risk-stratification evidence remains observational, retrospective, population-specific, or focused on a particular disease manifestation; therefore, prediction models should support—not replace—clinical assessment. [926][801][969]
Immediate clinical severity assessment
Patients should first be assessed for acute physiological instability, respiratory compromise, altered mental status, shock, or evidence of multiorgan dysfunction, because disseminated tuberculosis can produce multiple-organ dysfunction and has a high mortality risk. [969] HIV-associated tuberculosis is a particularly high-risk phenotype: in a prospective cohort of adults admitted with severe HIV-associated TB, systemic Mycobacterium tuberculosis bacillary load, inflammatory responses, and age were evaluated as interacting determinants of mortality. [879] These findings support documenting HIV status, age, estimated bacillary burden, and sepsis-related inflammatory features when determining urgency and level of care. [879]
Disease distribution is a major severity determinant. Disseminated TB should be actively considered when extrapulmonary or multisystem involvement is present, particularly in patients with laboratory patterns or lymphocyte-subset abnormalities suggestive of dissemination. [969] Central nervous system involvement substantially changes risk: a large inpatient study compared pulmonary TB with pulmonary TB complicated by CNS tuberculosis and further classified CNS-TB using Medical Research Council grades, with Grades II–III representing greater neurological severity than Grade I. [967]C Neurological examination, mental-status assessment, and evaluation for focal deficits are therefore essential whenever CNS disease is suspected. [967]C
Spinal TB requires separate neurological and structural assessment. Thoracic spinal disease may cause vertebral destruction, spinal instability, and neurological deficits; paraplegia at presentation was investigated using clinical, laboratory, and imaging variables in a surgical cohort, and a clinical-imaging severity framework was developed. [804] Red-flag assessment should include motor weakness, sensory change, sphincter dysfunction, spinal deformity, instability, and imaging evidence of cord compression or extensive vertebral destruction. [804] Inappropriate vertebral augmentation may aggravate spinal TB lesions and worsen clinical symptoms, so unexplained postoperative deterioration or atypical vertebral disease should prompt reassessment for TB. [802]C
Pulmonary and systemic severity domains
Pulmonary severity should incorporate symptom burden, respiratory status, radiological extent, and laboratory evidence of systemic inflammation. A study integrating clinical, radiological, and laboratory variables identified separate systemic and pulmonary severity dimensions using factor analysis of mixed data and combined them into an overall severity score. [885] Circulating IgG responses against ESAT-6/CFP-10, Ag85A, HspX, and Rv2626c were investigated as antigen-specific signatures associated with mild and severe TB phenotypes; these findings are promising but should be regarded as investigational rather than stand-alone clinical thresholds. [885]
Host immune profiles may provide additional stratification. In pulmonary TB complicated by CNS-TB, immune-inflammatory parameters were compared with pulmonary TB alone after propensity matching, and CNS-TB was further stratified by MRC grade. [967]C CD4+CD8+ double-positive T cells and other immune-cell traits have also been studied in relation to TB susceptibility, severity, and treatment outcomes using genome-wide association and cohort data. [890] Neither study establishes a universally validated bedside cutoff, so immune-cell measurements should not supersede standard clinical, neurological, microbiological, and radiological assessment. [967]C[890]
Prognostic risk groups
Drug-resistant TB should be considered a high-risk prognostic category requiring individualized mortality-risk assessment. A systematic review and meta-analysis synthesized adjusted hazard ratios from longitudinal survival studies of patients with any form of drug-resistant TB, focusing on factors associated with all-cause mortality. [909] The evidence supports using survival-based prognostic factors alongside resistance pattern, treatment response, comorbidity, nutritional status, and organ involvement, although the supplied evidence does not establish one universal mortality score or threshold. [909]
Post-treatment risk should also be recognized. Adults completing standard treatment for pulmonary TB were followed prospectively with repeated symptom and lung-function assessments to identify predictors of COPD after TB cure, reflecting persistent risk of chronic respiratory impairment even after microbiological treatment completion. [237]B2b Follow-up should therefore include respiratory symptoms and lung function when clinically indicated, especially in patients with substantial pulmonary disease or ongoing functional limitation. [237]B2b
Risk prediction and model use
Risk-prediction models are increasingly used for TB diagnosis, dissemination, treatment outcomes, and drug toxicity. A systematic review of East Asian models identified 26 studies and 31 models for anti-tuberculosis drug-induced liver injury, emphasizing the potential for early identification of high-risk individuals and personalized treatment planning. [926] These models should be interpreted according to their population, predictors, discrimination, calibration, and external validation, because performance may not transfer across regions or clinical settings. [926]
A systematic review of African studies reported use of Bayesian methods, machine learning, spatiotemporal analysis, time-series models, and multistate or survival frameworks for TB diagnosis and treatment outcomes. [801] Such methods may improve handling of diagnostic uncertainty, spatial heterogeneity, and complex disease dynamics, but methodological sophistication alone does not establish clinical utility. [801] A machine-learning model for disseminated TB in HIV-negative hospitalized patients used conventional laboratory tests and multidimensional lymphocyte-subset analysis, screened nine significant features, and applied SHAP analysis to explain feature importance. [969]
Practical interpretation
A patient should be considered high risk when TB is accompanied by haemodynamic or respiratory instability, suspected dissemination, CNS involvement, paraplegia or cord compression, high pathogen burden, severe inflammatory or sepsis features, HIV-associated disease, drug resistance, or substantial comorbidity and functional impairment. [879][967]C[969][804][909] Conversely, absence of these features does not exclude clinically important disease, and severity should be reassessed dynamically as microbiological, radiological, neurological, and treatment-response information accumulates. [885][801]
The provided fever-and-neutropenia guideline concerns children and adolescents with cancer rather than TB and should not be used as a TB severity tool. [400]A1c Similarly, the peritoneal-dialysis peritonitis study addresses pathogen detection in a non-TB infection and provides no TB severity threshold. [410]B2b Studies of TB knowledge and patient delay address risk perception or health-seeking behavior rather than biological disease severity; patient delay is nevertheless associated with mortality risk at the population level and should be addressed through earlier recognition and access to care. [780][970] Population-based emergency-diagnosis evidence in non-neoplastic conditions is not sufficient to define TB-specific severity categories. [968]
| Domain | High-risk indicators supported by the evidence |
|---|---|
| Acute physiology | Respiratory or haemodynamic instability, sepsis features, or multiorgan dysfunction [879][969] |
| Distribution | Disseminated TB or CNS involvement [969][967]C |
| Neurological/spinal | MRC Grade II–III CNS-TB, paraplegia, cord compression, instability, or extensive vertebral destruction [967]C[804] |
| Host and pathogen | HIV-associated TB, older age, high bacillary burden, and marked inflammatory response [879] |
| Resistance and toxicity | Drug-resistant TB or high predicted risk of anti-TB drug-induced liver injury [909][926] |
| Longer-term outcome | Persistent respiratory impairment or risk of COPD after pulmonary TB treatment [237]B2b |
Empiric Management, Acute Care and Source Control
- ▸No supplied reference establishes a new universal empiric regimen for active TB; initiate only when delay is unsafe and revise promptly using resistance results. [923][980]
- ▸Assess renal function before treatment and individualize ethambutol exposure and monitoring. [976][977]
- ▸Pregnancy, HIV therapy, spinal disease, and neurological compromise require early specialist coordination. [972][974][956]
- ▸Negative bacteriology does not automatically exclude pulmonary TB; reassess specimen quality, alternative diagnoses, and the risk-benefit of empiric treatment. [975]
- ▸Use diagnostic sampling, drainage, or decompression for source control when indicated; surgery is complication-driven rather than routine. [956][981]
Scope and immediate priorities
Empiric management should be reserved for patients in whom the probability of active tuberculosis (TB) and the consequences of delaying treatment are high, particularly when there is severe pulmonary disease, suspected central nervous system involvement, spinal disease with neurological compromise, disseminated disease, or substantial immunosuppression. The supplied evidence does not provide a new universal empiric drug regimen or dosing schedule; treatment selection must therefore remain individualized and consistent with current local or national TB-program guidance, while awaiting microbiological and resistance results. This limitation is important because drug-resistant TB remains a major management problem, with treatment coverage estimated at only 42% globally in 2024 among people with multidrug- or rifampicin-resistant TB. [942]
At presentation, assess airway, breathing, circulation, oxygenation, mental status, sepsis physiology, haemoptysis, neurological deficits, spinal instability, renal function, pregnancy, HIV status, and drug-interaction risk. Obtain respiratory, blood, cerebrospinal-fluid, tissue, or other site-specific specimens before treatment whenever this can be done safely and without clinically important delay. Molecular testing that detects Mycobacterium tuberculosis and rifampicin resistance should be prioritized where available; resistance-associated variants can materially change treatment decisions, but molecular results may require confirmatory testing and must be interpreted according to the assay’s validated scope. [980]D
Starting empiric therapy
When treatment cannot safely await culture or complete susceptibility testing, begin an empiric regimen that covers the most likely resistance pattern and disease site, then revise it promptly when molecular, phenotypic, or sequencing data become available. Do not use a single-drug approach or extrapolate a regimen from preventive therapy to treatment of established disease. A 2026 systematic review and network meta-analysis specifically addressed preventive TB regimens in children and adolescents under 18 years with TB infection or contact with drug-susceptible TB, without HIV; its population and objective do not establish treatment regimens for active TB. [923]
Before prescribing, document previous TB treatment, prior drug exposure, contact with drug-resistant TB, baseline microbiology, weight, pregnancy, renal function, liver risk, visual status when ethambutol is considered, and concomitant medicines. Renal assessment is particularly relevant because reduced estimated glomerular filtration rate is associated with less favorable TB-treatment outcomes, and pretreatment renal impairment is sufficiently important to warrant early identification. [977] Ethambutol exposure varies between patients; pharmacokinetic/pharmacodynamic analyses have examined lower exposure, treatment efficacy, and safety, supporting weight-, renal-, and clinically informed dosing and monitoring rather than uncritical fixed dosing. [976]
In pregnancy, coordinate TB and obstetric care early. Spinal TB in pregnancy creates simultaneous diagnostic, neurological, and obstetric challenges, and the available evidence is based on reported cases and small series rather than comparative trials. [972]C For pregnant people living with HIV, efavirenz pharmacokinetics have been studied during pregnancy and postpartum while participants received rifampicin/isoniazid-based TB treatment with or without ethambutol and pyrazinamide; this supports deliberate review of antiretroviral–TB-drug interactions and pregnancy/postpartum changes in exposure. [974]C
Acute care and monitoring
Admit or escalate care for hypoxaemia, respiratory failure, massive or recurrent haemoptysis, shock, altered consciousness, seizures, rapidly progressive neurological findings, spinal cord or cauda equina compression, severe drug toxicity, or inability to take or absorb oral treatment. For spinal disease, urgent MRI and specialist assessment are appropriate when pain is accompanied by weakness, sensory change, sphincter symptoms, deformity, or suspected instability. In a London retrospective cohort of 62 patients with spinal TB, back or neck pain was the predominant symptom and thoracic involvement was frequent, illustrating why persistent axial pain should not be managed as uncomplicated musculoskeletal disease when TB is plausible. [956]C
Monitor clinical response, adherence, toxicity, microbiological conversion when measurable, and complications at every review. A clinically diagnosed pulmonary TB category exists despite negative bacteriological results and accounted for a substantial proportion of pulmonary TB notifications in the cited Zambian cohort; therefore, a negative initial test should trigger reassessment of specimen quality, alternative diagnoses, imaging, and the justification for continuing or stopping empiric treatment rather than automatic dismissal of TB. [975] Psychosocial distress, stigma, concern about adverse effects, and treatment duration can undermine adherence; counselling is a proposed patient-centred intervention, although the cited cluster-randomized trial is a protocol and does not yet establish effectiveness. [978]D
Source control and procedural management
Source control in TB means obtaining adequate diagnostic material, draining or decompressing clinically significant collections, and relieving mechanical complications—not routine surgical removal of every lesion. Obtain tissue or aspirate from accessible lymph nodes, pleural collections, abscesses, or other extrapulmonary sites when this will improve diagnostic certainty or resistance testing. Histopathology and cytology remain reference methods for lymph-node lesion characterization, while rapid on-site evaluation may help guide sampling; however, the cited AI study addresses diagnostic workflow rather than therapeutic outcomes. [981]D
Consider urgent surgical or interventional consultation for spinal cord compression, progressive neurological deficit, instability, major deformity, large symptomatic abscess, or failure of medical management. Surgery should be individualized because the available spinal-TB evidence is retrospective or case-based, not definitive comparative evidence. [956]C[972]C In pulmonary disease, manage life-threatening haemoptysis and respiratory compromise as emergencies while continuing diagnostic and infection-control measures. Patients with suspected infectious pulmonary TB should receive appropriate airborne precautions and public-health referral; the supplied references do not quantify isolation duration.
Drug-resistant disease and reassessment
If rifampicin resistance, multidrug resistance, treatment failure, recurrence, or epidemiological risk is identified, obtain expert TB consultation immediately and avoid piecemeal addition of drugs. Treatment should be reconstructed using the complete resistance profile, disease site, prior exposure, comorbidities, interactions, and susceptibility to toxicity. Mortality in drug-resistant TB remains substantial, and prognostic factors have been synthesized in survival-based systematic review evidence, reinforcing the need for early identification of high-risk patients and close follow-up. [909] Pre-XDR and XDR-TB prevalence has also been specifically studied among MDR-TB cases in Ethiopia, underscoring the need for resistance characterization rather than assuming that all MDR/RR-TB is therapeutically equivalent. [973]
| Domain | Immediate action |
|---|---|
| Instability | Assess oxygenation, ventilation, circulation, mental status, haemoptysis, and sepsis physiology; escalate urgently when abnormal. [975] |
| Microbiology | Collect site-appropriate specimens before therapy when safe; request molecular resistance testing and confirmatory testing when indicated. [980]D |
| Comorbidity | Check renal function, pregnancy status, HIV/antiretroviral therapy, prior TB treatment, and interacting medicines. [972]C[974]C[977] |
| Complication | Urgently evaluate neurological deficit, spinal instability, cord compression, major abscess, or respiratory compromise. [956]C[972]C |
| Follow-up | Monitor response, adherence, toxicity, and microbiological conversion; revise treatment when resistance data return. [909][980]D |
Definitive Therapy: Dosing, PK/PD, Duration and De-escalation
- ▸Randomized evidence evaluates standard 6-month, modified 6-month, 4-month, and intended 8-week DS-PTB strategies, but the supplied abstract does not provide regimen-specific doses or relapse estimates; shortening should not be generalized from duration alone. [982]
- ▸A **6-month** multidrug course remains the conventional DS-PTB framework in the supplied evidence, with de-escalation individualized to susceptibility, response, and safety. [982]
- ▸Ethambutol PK/PD data support attention to exposure and covariates, but no universal target or dose algorithm is reported in the supplied abstract. [976]
- ▸Pregnancy can alter the interaction context for efavirenz with rifampin/isoniazid therapy across gestation and postpartum; numeric dose recommendations are not provided. [974]
- ▸Contezolid switching after linezolid intolerance and levofloxacin use in congenital TB remain limited-evidence, specialist interventions. [983, 985]
Scope and treatment architecture
The supplied evidence supports individualized selection of definitive therapy according to drug susceptibility, disease site, pregnancy, age, comorbidity, toxicity risk, and drug exposure, but it does not provide a replacement for guideline-based standard dosing. In adults and adolescents with drug-susceptible pulmonary tuberculosis (DS-PTB), randomized-trial evidence has evaluated standard 6-month therapy, rifamycin-intensified regimens, structurally modified 6-month regimens, 4-month treatment-shortening strategies, and intended 8-week regimens; the comparative emphasis is treatment completion and relapse prevention rather than duration alone. [982] Because the supplied abstract does not report the individual regimens, doses, noninferiority margins, or pooled relapse estimates, specific shortened regimens should not be adopted solely from this citation. [982]
Duration and de-escalation
The conventional DS-PTB framework remains a multidrug course of approximately 6 months, while shorter regimens are an evidence-based research and implementation priority rather than a universal default. [982] De-escalation should therefore mean progression from an intensive multidrug phase to a continuation phase only when microbiologic results, susceptibility testing, clinical response, and safety monitoring support preservation of an active regimen; the supplied references do not establish a new universal de-escalation threshold. [982]
Radiographic improvement alone should not dictate shortening or discontinuation. In a prospective cohort of 38 adults with newly diagnosed microbiologically confirmed DS-PTB, early structural lung damage was assessed after the 2-month intensive phase, emphasizing that abnormalities can persist at the point when phase-based treatment decisions are commonly made. [963] Persistent structural change is therefore a post-treatment lung-disease risk marker, not by itself proof of treatment failure or an indication for indefinite antimicrobial therapy. [963]
For spinal TB, available evidence is observational: a London retrospective series included 62 patients and followed clinical and MRI findings from presentation through treatment completion, while a systematic review of spinal TB in pregnancy synthesized case reports and small series. [956]C[972]C These studies do not validate shortened therapy, PK-guided dosing, or a fixed de-escalation schedule for spinal disease or pregnancy. [956]C[972]C Pregnancy-associated spinal TB requires multidisciplinary assessment of neurological, obstetric, and fetal risks; treatment duration should be individualized because the evidence base is descriptive and case-based. [972]C
PK/PD and drug-specific considerations
Ethambutol population PK/PD analysis from Study 31/ACTG A5349 used data from 1,493 participants and 3,077 plasma samples to investigate covariates associated with exposure, relationships between exposure and efficacy, and safety outcomes. [976] This supports exposure-aware dosing when clinically indicated, especially where renal function, body size, or other factors may produce low exposure, but the supplied abstract does not report a validated target exposure, dose adjustment algorithm, or threshold that can be applied universally. [976]
Rifampin- and isoniazid-containing tuberculosis treatment can be clinically important in people with HIV receiving efavirenz. IMPAACT P1026s evaluated intensive 24-hour efavirenz PK during pregnancy, the second and third trimesters, and 2–8 weeks postpartum, including participants receiving rifampin and isoniazid with or without ethambutol and pyrazinamide. [974]C The study directly addresses pregnancy-related and tuberculosis-drug-related changes in efavirenz AUC, peak and trough concentrations, and apparent clearance; however, the supplied abstract does not provide numeric results or a revised efavirenz dose. [974]C Antiretroviral and tuberculosis regimens should therefore be reconciled deliberately, with attention to pregnancy and postpartum transitions rather than assuming stable exposure. [974]C
Toxicity-directed modification
Anti-tuberculosis drug-induced liver injury is sufficiently consequential that risk prediction models have been systematically evaluated in East Asian populations. The review identified 26 studies and 31 prediction models, but the supplied abstract does not provide a single validated model, universal risk threshold, or treatment-rechallenge protocol. [926] Risk stratification may inform monitoring intensity and selection of alternative agents, but it should not substitute for clinical assessment, serial liver tests, or evaluation of competing causes of liver injury. [926]
In tuberculous meningitis, a retrospective comparison included 16 patients receiving contezolid, including nine who switched from linezolid because of intolerance, and 32 receiving linezolid. [983]C The study was designed to assess comparable efficacy and safety, but its retrospective, small-sample design does not establish contezolid as routine first-line therapy or define a standard dose, duration, or switch threshold. [983]C Contezolid may be considered a toxicity-driven alternative only in specialist care when the expected benefits outweigh the limited evidence base. [983]C
Levofloxacin-containing regimens have been reported in congenital TB, but the available evidence consists of two new cases plus 18 cases from 17 reports; at least 16 of 20 patients were preterm. [985]C This case-based evidence cannot define neonatal dosing, PK targets, treatment duration, or routine de-escalation, and management should remain specialist-led. [985]C
Implementation and safety
Older adults with MDR/RR-TB may be lost before or during treatment: a Chinese retrospective cohort of 667 patients aged ≥65 years examined attrition across diagnosis, treatment initiation, and retention stages. [932] This supports early, coordinated treatment initiation and adherence support, but it does not identify a definitive MDR/RR-TB regimen or dosing strategy. [932] Psychosocial counseling is being evaluated as a cluster-randomized adherence intervention for newly diagnosed TB, but the cited work is a protocol and therefore provides no efficacy result yet. [978]D Finally, inflammatory worsening during treatment can represent a paradoxical reaction: a prospective study of HIV-negative patients defined it by new or increased tachypnea with hypoxemia or oxygen requirement after alternative causes were excluded. [986]D Such deterioration should trigger reassessment for treatment failure, toxicity, resistance, or paradoxical inflammation rather than automatic regimen escalation. [986]D
| Clinical situation | Evidence-supported implication | Limitation |
|---|---|---|
| DS-PTB | Consider standard 6-month therapy or a validated shortened regimen when eligibility criteria are met. [982] | Supplied abstract lacks regimen-specific doses and relapse estimates. [982] |
| Possible low ethambutol exposure | Consider PK-informed review of covariates and adherence. [976] | No universal PK target or dosing algorithm reported. [976] |
| Pregnancy with HIV and TB | Reassess efavirenz exposure across pregnancy and 2–8 weeks postpartum. [974]C | No numeric adjustment recommendation supplied. [974]C |
| Linezolid intolerance in TB meningitis | Specialist consideration of contezolid is supported by limited retrospective data. [983]C | Small, nonrandomized cohort; no standard switch threshold. [983]C |
| Liver-injury risk | Use risk-informed monitoring and clinical assessment. [926] | No single validated prediction model or threshold established. [926] |
History and Evolution of Treatment
- ▸TB treatment has evolved from standardized antimicrobial therapy toward individualized, toxicity-aware, adherence-supported, and rehabilitation-inclusive care. [1001]
- ▸MDR/RR-TB remains a major global treatment challenge: approximately **390,000** cases occurred in 2024, while treatment coverage was **42%**. [942]
- ▸Injectable-associated hearing loss and anti-TB drug-induced liver injury have accelerated the development of active safety monitoring and risk prediction. [989] [926]
- ▸Modern care increasingly includes electronic adherence monitoring, integrated HIV treatment, response imaging, recurrence prevention, and post-TB pulmonary rehabilitation. [1006] [997] [1002] [941] [1000]
From uniform short-course therapy to individualized care
Modern tuberculosis (TB) treatment evolved from prolonged, toxic regimens toward standardized multidrug therapy selected according to disease site, drug-susceptibility results, HIV status, age, comorbidity, and treatment response. The contemporary challenge is no longer limited to killing Mycobacterium tuberculosis: effective care also requires preventing resistance, retaining patients in care, managing toxicity, treating coexisting disease, and addressing residual disability. Recent evidence describes TB as a biopsychosocial condition in which biological vulnerability, psychological factors, social circumstances, and access to care jointly influence outcomes. [1001]
Drug-susceptible and drug-resistant TB
The evolution of treatment has been particularly pronounced for multidrug- and rifampicin-resistant TB (MDR/RR-TB). Research has shifted from describing resistance phenotypes to investigating resistance-associated mutations, bacterial adaptation, host–pathogen interactions, and drug-target mechanisms. [942] Despite therapeutic advances, approximately 390,000 people developed MDR/RR-TB in 2024, while treatment coverage was only 42%, demonstrating that regimen innovation has not eliminated access and implementation gaps. [942]
Treatment history is also shaped by the toxicity of older injectable-based regimens. In a nationwide prospective study of rifampicin-resistant TB, 45.4% of patients without severe baseline hearing loss developed treatment-emergent hearing loss and 23.5% developed treatment-emergent severe hearing loss; monthly pure-tone audiometry and cumulative-dose assessment were used to support safety monitoring. [989] These findings illustrate the movement toward active drug-safety monitoring and away from relying solely on clinical symptoms. Predictive medicine is similarly developing for anti-TB drug-induced liver injury: a systematic review identified 31 risk-prediction models from 26 studies in East Asian populations, although model performance and clinical applicability require careful evaluation before routine adoption. [926]
Patient-centered delivery and adherence
The history of TB treatment has progressively incorporated adherence support, counseling, and differentiated care. Among older adults with MDR/RR-TB in China, a care-cascade analysis demonstrated substantial attrition before and during treatment, emphasizing that diagnosis alone does not ensure treatment initiation or retention. [932] Mortality risk in drug-resistant TB is now being examined through survival-based prognostic factors rather than treatment completion alone, reflecting a broader focus on risk stratification and individualized follow-up. [909]
In patients with MDR-TB and HIV, adherence to bedaquiline and antiretroviral therapy was studied using electronic dose monitoring and natural-language processing of routine counseling notes. The analysis examined whether the timing and content of counseling were associated with longitudinal adherence, supporting the use of routinely collected care information to tailor adherence interventions. [1006] HIV treatment itself is also evolving toward long-acting delivery: a randomized trial in virologically suppressed adolescents in sub-Saharan Africa evaluated cabotegravir–rilpivirine injections every 8 weeks versus daily oral antiretroviral therapy. [997] Although this was an HIV-treatment study rather than a TB regimen study, it is relevant to the integrated management of TB/HIV, in which pill burden, adherence, and coordinated delivery remain central concerns. [997]
Response monitoring and diagnostic refinement
Treatment monitoring is expanding beyond symptoms, sputum microbiology, and conventional imaging. In extrapulmonary TB, serial 18F-FDG PET/CT was evaluated as an adjunct for monitoring metabolic treatment response, particularly when conventional microbiological assessment is difficult; the available evidence is retrospective and observational. [1002] Diagnostic uncertainty remains important because clinically diagnosed pulmonary TB—defined despite negative bacteriological results—represented 36% of global pulmonary TB notifications in the cited analysis, and was associated with mortality outcomes in a prospective Zambian cohort. [975]
The treatment pathway must also protect against misdiagnosis. Disseminated Aspergillus flavus infection can mimic spinal TB and lead to delayed diagnosis and inappropriate anti-TB therapy, including in an apparently immunocompetent host. [1004] Pediatric TB meningitis continues to require early recognition and urgent treatment because delayed diagnosis may progress to encephalitis and irreversible neurological injury. [911]C Pediatric tuberculous pleural empyema has likewise often required extensive thoracic surgery, with operative scope determined by disease stage and complications; a retrospective cohort covered treatment across historical eras from 1984–2022. [990]C
Prevention, recurrence, and long-term outcomes
TB care increasingly includes prevention and post-treatment management. BCG vaccination and household exposure remain important determinants of childhood TB risk in high-transmission, resource-limited communities, although effectiveness varies by setting. [936] For people with repeated exposure risk, including international travelers, repeat TB testing and linkage to preventive treatment are being reconsidered because existing guidance may not fully address travel-associated conversion. [1003] Recurrence remains a concern among vulnerable groups including people living with HIV, prisoners, informal miners, smokers, children, and rural populations. [941]
Finally, microbiological cure is no longer regarded as the endpoint of treatment. Post-tuberculosis lung disease may cause persistent ventilatory impairment, reduced exercise capacity, respiratory-muscle weakness, and impaired quality of life. In a randomized trial of 120 adults with confirmed post-TB lung disease, structured pulmonary rehabilitation combined with inspiratory-muscle training was evaluated against standard care. [1000] This represents a shift toward rehabilitation and survivorship care. Future treatment strategies must also account for co-endemic infections and diagnostic overlap, including helminth infections and Hansen disease in populations where these conditions coexist. [1005] Long-term epidemiological surveillance, including trends in drug-susceptible, drug-resistant, and HIV-associated TB, remains necessary to align treatment policy with changing disease patterns. [937]
| Treatment era or priority | Evolution in practice | Supporting evidence |
|---|---|---|
| Antimicrobial standardization | From uniform therapy toward regimens informed by resistance mechanisms and patient characteristics | [942] [1001] |
| Drug-resistant TB | From prolonged, toxic injectable exposure toward safety-monitored and risk-stratified management | [989] [909] [932] |
| Adherence and comorbidity | From medication delivery alone toward counseling, electronic monitoring, and coordinated TB/HIV care | [1006] [997] |
| Response assessment | From symptoms and routine microbiology toward adjunctive metabolic imaging in selected extrapulmonary disease | [1002] |
| Post-treatment care | From microbiological cure as the endpoint toward rehabilitation for post-TB lung disease | [1000] |
Antimicrobial Resistance and Stewardship
- ▸Global MDR/RR-TB burden remains high: approximately 390,000 cases occurred in 2024, while treatment coverage was 42%. [942]
- ▸WGS, phenotypic DST, targeted molecular testing, and lineage surveillance should be used complementarily rather than interchangeably. [980] [987] [992]
- ▸Resistance interpretation must include coding mutations, regulatory mutations, minority variants, and the clinical significance of individual genomic findings. [980] [995]
- ▸Injectable-agent ototoxicity is frequent and supports baseline and monthly audiometry when such drugs are used. [989]
- ▸Treatment success estimates are weakened by attrition and “not evaluated” outcomes, making care-cascade monitoring and accountable reporting central stewardship functions. [932] [991]
- ▸New drug targets and validated diagnostics are needed because prolonged therapy, adverse effects, adherence problems, and fluoroquinolone resistance continue to limit treatment effectiveness. [980] [993]
Global burden and stewardship priorities
Drug-resistant tuberculosis (DR-TB) remains a major obstacle to tuberculosis control. An estimated 390,000 people developed multidrug- or rifampicin-resistant tuberculosis (MDR/RR-TB) in 2024, while treatment coverage was only 42%, indicating substantial gaps in diagnosis, linkage to care, and effective treatment delivery. [942] Resistance is shaped by resistance-associated mutations, bacterial adaptation, host–pathogen interactions, and drug–target processes; contemporary research is increasingly focused on connecting these mechanisms with clinical decisions. [942]
Stewardship should therefore prioritize rapid resistance detection, reliable susceptibility interpretation, individualized regimen selection, adherence support, toxicity monitoring, and complete outcome ascertainment. Prolonged or poorly tolerated therapy can compromise adherence and promote further resistance, reinforcing the need for effective multidrug regimens and development of new agents. [993]D
Resistance surveillance and epidemiology
Resistance surveillance requires integration of phenotypic drug-susceptibility testing (DST), targeted molecular assays, and whole-genome sequencing (WGS). In a multicentre Ukrainian cohort collected during 2019–2023, WGS was completed for 4,162 Mycobacterium tuberculosis complex isolates; 3,112/4,162 (74.8%) were at least rifampicin-resistant. The study evaluated resistance profiles, population structure, genomic clustering, and temporal trends in the context of the COVID-19 pandemic, population displacement, health-system disruption, and policy changes. [987]
WGS-based surveillance can identify resistance-associated variants, infer phylogenetic relationships, detect transmission clusters, and support regional monitoring. In Lebanon, WGS of 218 isolates collected during 2018–2024, with 196 passing quality control, was compared with phenotypic DST and line-probe assays to assess lineages, resistance mutations, and transmission dynamics. [992]D However, genomic predictions require careful interpretation because the clinical meaning of individual variants depends on assay validity, exact variant detection, drug-level inference, and the anticipated impact on treatment decisions. [980]D
The Beijing lineage is globally distributed and has been associated with high transmissibility and multidrug resistance. A systematic review and meta-analysis evaluated its prevalence by molecular-typing method, WHO region, and time period, supporting lineage-aware surveillance and investigation of its continued expansion. [988] In China, long-term epidemiological modelling through 2023 separately examined drug-resistant tuberculosis, including MDR and extensively drug-resistant tuberculosis, and projected future trends, emphasizing the continuing need for surveillance despite overall progress in TB control. [937]
Molecular mechanisms and diagnostics
Resistance research increasingly links mutations to specific drugs and actionable treatment decisions. A review of CRISPR-enabled diagnostics emphasized that useful assays should detect M. tuberculosis, identify resistance-associated variants, preserve minority alleles, support direct-specimen testing, and indicate when broader confirmatory testing or sequencing is needed. Current evidence remains dominated by analytical studies, isolate-based evaluations, and small direct-specimen investigations, so prospective multicentre validation remains necessary. [980]D
Para-aminosalicylic acid resistance has been investigated through 6,547 clinical M. tuberculosis whole-genome sequences. Researchers identified 29 single-nucleotide polymorphisms in the dfrA coding region and 8 mutations in the upstream thyA–dfrA region, with selected variants assessed using thermal-stability studies, GFP reporter assays, and para-aminosalicylic-acid susceptibility testing. These findings support examination of both coding and regulatory mutations when interpreting resistance. [995]D
Curated resources can improve stewardship by linking resistance mutations, drugs, diagnostic methods, epidemiology, and treatment evidence. MTB-KB integrates 75,170 associations from 1,246 publications, covering 18,439 standardized entities across major areas of TB research, including drug resistance and treatment. [994]D
Treatment safety, adherence, and outcomes
Safety monitoring is an essential component of DR-TB stewardship because toxicity can lead to interruption, regimen modification, or treatment abandonment. In a nationwide prospective study of patients receiving injectable agents for rifampicin-resistant TB, 89/196 (45.4%) patients without severe baseline hearing loss developed treatment-emergent hearing loss and 46/196 (23.5%) developed treatment-emergent severe hearing loss. Baseline and monthly pure-tone audiometry, cumulative-dose assessment, and weight-standardized exposure analysis were used to evaluate risk. [989]
Care-cascade losses may be particularly important in older adults. A retrospective study of 667 patients aged ≥65 years with MDR/RR-TB in Guangdong, China, constructed a cascade from diagnosis through treatment initiation, six-month retention, and later outcomes, aiming to identify age-specific barriers to continued care. [932] Mortality remains substantial in DR-TB, and a systematic review and meta-analysis synthesized adjusted hazard ratios from longitudinal survival studies to identify prognostic factors for death. [909]
Routine programme data should be interpreted cautiously when outcomes are incompletely evaluated. A 2020–2024 analysis from two rural Eastern Cape facilities examined DR-TB outcomes and highlighted the increasing proportion classified as “not evaluated,” which may reflect weaknesses in follow-up, reporting, or health-system accountability rather than clinical performance alone. [991]
Special populations and implementation safeguards
Resistance assessment should not be limited to pulmonary disease. A retrospective study of extrapulmonary TB in Fuyang, China, compared IGRA, GeneXpert MTB/RIF Ultra, and culture, and performed DST on culture-positive isolates; MDR was defined as resistance to at least isoniazid and rifampicin. [933] Congenital TB may require specialist regimen design: a review of 20 reported infants and children treated with levofloxacin-containing regimens found that at least 16/20 (80%) were preterm, underscoring the need to balance resistance-directed therapy with age-specific safety and pharmacology. [985]C
Novel drug discovery remains a stewardship priority because fluoroquinolone resistance limits an important TB drug class. Fragment-based screening identified an unprecedented allosteric binding site in M. tuberculosis DNA gyrase, an attractive target because M. tuberculosis lacks topoisomerase IV and relies on DNA gyrase as its sole type II topoisomerase. [993]D
| Domain | Practical priority | Evidence |
|---|---|---|
| Detection | Perform rapid molecular resistance testing and confirm or extend testing with DST or WGS when indicated. | [980]D [987] [992]D |
| Interpretation | Assess exact variants, minority alleles, regulatory mutations, and drug-level implications before changing therapy. | [980]D [995]D |
| Surveillance | Combine resistance profiles with lineage, clustering, and temporal data. | [987] [988] [992]D |
| Safety | Monitor hearing at baseline and monthly when injectable agents are used; consider cumulative and weight-standardized exposure. | [989] |
| Programme performance | Track diagnosis, initiation, retention, death, and “not evaluated” outcomes separately. | [932] [909] [991] |
Complications
- ▸PTLD can cause persistent ventilatory impairment, exercise limitation, respiratory-muscle weakness, and reduced quality of life after microbiological cure. [1000]
- ▸TBM complications include hydrocephalus, vasculitic infarcts, cranial-nerve palsies, neurological sequelae, and paradoxical deterioration; paradoxical reaction was reported at approximately **30%** in one prospective study. [911,1004]
- ▸Pregnancy-associated spinal TB has maternal neurological and fetal/obstetric risks, but evidence is limited mainly to case reports and small series. [972]
- ▸Preventive-treatment adverse events may cause discontinuation, particularly in people receiving immunosuppressive medication; pediatric regimen safety has been evaluated in randomized evidence. [923,999]
- ▸Ethambutol exposure varies between individuals, supporting attention to pharmacokinetic factors and safety monitoring. [976]
Tuberculosis (TB) complications arise from direct tissue injury, dissemination, immune-mediated inflammation, comorbidity, pregnancy, or toxicity from treatment. The supplied evidence is heterogeneous: it includes randomized trials, systematic reviews, observational cohorts, case series, and mechanistic studies, so reported risks are not directly comparable across populations.
Pulmonary and post-tuberculosis complications
Pulmonary TB may leave persistent respiratory impairment despite microbiological cure, a condition termed post-tuberculosis lung disease (PTLD). In a randomized trial, adults with microbiologically confirmed PTLD and spirometric impairment were evaluated for ventilatory limitation, respiratory-muscle weakness, exercise intolerance, and reduced health-related quality of life; the trial specifically assessed structured pulmonary rehabilitation with inspiratory-muscle training against standard care. [1000] These sequelae can therefore persist after completion of anti-TB treatment and should be distinguished from active, recurrent, or treatment-resistant disease. [1000]
Altered lipid metabolism has also been reported in pulmonary TB, particularly when diabetes mellitus is present. A systematic review and meta-analysis compared high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, and total cholesterol among people with TB and diabetes, TB alone, and diabetes alone, indicating that metabolic complications and cardiometabolic comorbidity are relevant considerations during TB care. [925]
Central nervous system tuberculosis
Tuberculous meningitis (TBM) is a severe extrapulmonary complication associated with mortality and neurological disability. Pediatric TBM may progress from meningeal inflammation to encephalitic involvement, with potentially irreversible neurological sequelae when recognition is delayed. [911]C Reported pediatric complications include neurological deterioration and other acute adverse outcomes, although the available modern-era evidence was based on a small retrospective series of 21 patients. [911]C
Inflammatory complications of TBM include basal exudates, cerebral vasculitic infarction, hydrocephalus, cranial-nerve palsies, and paradoxical clinical deterioration during treatment. [1004] In a prospective study of 151 treatment-naïve patients meeting Marais consensus criteria, paradoxical reaction was described as occurring in approximately 30% of patients; the study evaluated baseline serum and cerebrospinal-fluid inflammatory biomarkers as predictors of paradoxical reaction and vasculitic infarction. [1004] A paradoxical reaction should be considered when neurological or radiological disease worsens after treatment has begun, while excluding treatment failure, drug resistance, poor adherence, and another diagnosis. [1004]
Small observational evidence suggests that contezolid may be used in TBM when linezolid intolerance limits therapy. In a retrospective cohort, 9 of 16 patients in the contezolid group had switched from linezolid because of intolerance; the study compared 16 contezolid-treated patients with 32 receiving linezolid and reported comparable efficacy with a favorable safety profile, but its non-randomized design and small sample limit conclusions. [983]C
Pregnancy and fetal complications
Spinal TB during pregnancy creates simultaneous diagnostic, neurological, and obstetric challenges. A systematic review of case reports and case series evaluated maternal neurological recovery, reported live births, and other maternal and fetal outcomes, but the evidence was descriptive and based on isolated cases and small series rather than comparative studies. [972]C Consequently, neurological compromise, obstetric complications, and fetal outcomes should be assessed individually, with multidisciplinary management. [972]C
Available pregnancy safety evidence for preventive treatment is reassuring but context-specific. In a propensity-score-weighted routine-care cohort from Uganda, isoniazid preventive monotherapy during pregnancy was evaluated among women living with HIV receiving antiretroviral therapy, using a composite outcome including miscarriage, stillbirth, low birth weight, neonatal complications, and maternal or neonatal death. [1002] Because this was an observational study, it can identify associations but cannot establish that preventive treatment causes or prevents these outcomes. [1002]
Treatment-related toxicity and preventive-treatment complications
Adverse events may lead to interruption or discontinuation of TB preventive treatment, particularly in people receiving or about to start immunosuppressive medication. A systematic review and meta-analysis included 27 studies and 3,184 participants and specifically estimated adverse-event-related discontinuation according to preventive-treatment regimen. [999] This population requires assessment for baseline comorbidity, interacting medications, hepatotoxicity symptoms, and adherence barriers before and during preventive treatment. [999]
In children and adolescents younger than 18 years without HIV who had TB infection or contact with drug-susceptible TB, a systematic review and network meta-analysis compared the effectiveness and safety of available preventive regimens using randomized controlled trials. [923] Pediatric regimen selection should therefore balance completion and protection against adverse effects, although the supplied abstract does not provide regimen-specific numerical estimates. [923]
Ethambutol toxicity remains clinically important because exposure varies between individuals. Population-pharmacokinetic and pharmacodynamic analysis from a large phase 3 trial examined factors associated with lower exposure and relationships between exposure, efficacy, and safety outcomes, supporting exposure-aware dosing and monitoring rather than assuming uniform pharmacokinetics. [976]
Other supplied studies provide context but do not establish new TB-complication rates: N-acetylcysteine was evaluated as an adjunct to first-line therapy in a 90-patient pulmonary-TB randomized trial with liver-function indices and adverse events as outcomes, [998] while a broader systematic review assessed N-acetylcysteine in critically ill patients with respiratory disease. [939] Advanced pulmonary drug-delivery systems may reduce systemic exposure in some applications, but formulation, deposition, clearance, and regulatory limitations remain. [1001] Safety data for M72/AS01 vaccination in people living with HIV were examined in a systematic review and meta-analysis, [996] whereas long-acting cabotegravir–rilpivirine was studied for virologically suppressed adolescents with HIV rather than as TB therapy. [997] Bone-marrow evaluation in adults with HIV may identify infectious, neoplastic, or inflammatory causes of cytopenia or fever, including conditions that can complicate assessment of disseminated TB. [928]C Immune-inflammatory profiling has also been studied in pulmonary TB complicated by CNS TB, with more severe disease characterized by clinical and laboratory differences in a large retrospective cohort. [967]C Finally, national epidemiological analyses emphasize the continuing importance of drug-resistant and HIV-associated TB surveillance, because these forms contribute to adverse outcomes and complicate treatment. [937][1003]
| Domain | Important complications or considerations | Evidence |
|---|---|---|
| Pulmonary | Post-tuberculosis ventilatory impairment, exercise limitation, respiratory-muscle weakness, impaired quality of life | [1000] |
| CNS | Hydrocephalus, vasculitic infarction, cranial-nerve palsies, encephalitic progression, neurological sequelae, paradoxical reaction | [911]C[1004] |
| Pregnancy | Maternal neurological compromise and adverse fetal or obstetric outcomes in spinal TB | [972]C[1002] |
| Metabolic | Lipid alterations in TB, particularly with diabetes mellitus | [925] |
| Treatment and prevention | Adverse-event-related discontinuation, regimen-specific tolerability, ethambutol exposure-related safety concerns | [923][976][999] |
Prognosis and Natural History
- ▸TPT reduces progression risk, but the duration of protection and its variation across TB-burden settings require setting-specific interpretation; the supplied abstract does not provide a definitive protection interval [924].
- ▸For DS-PTB, treatment duration alone does not establish durable cure; relapse prevention depends on regimen architecture and long-term follow-up [982].
- ▸DR-TB prognosis is substantially influenced by mortality risk, retention in care, treatment failure, and completeness of outcome ascertainment [909][1005][991].
- ▸In the Loreto cohort, 49.5% of DR-TB cases had an unsuccessful outcome, including 11.8% mortality and 34.1% loss to follow-up [1005].
- ▸Children living with HIV, people receiving immunosuppression, pregnant women living with HIV, and patients receiving immune-checkpoint inhibitors require individualized prognostic assessment because the available studies address distinct diagnostic, safety, or reactivation risks [1001][999][1003][1008].
Overview
Tuberculosis (TB) has a highly variable natural history. Infection may remain latent, progress to active disease, relapse after treatment, or recur after preventive-treatment protection wanes. The supplied 2026 evidence base is strongest for preventive-treatment durability, relapse prevention in drug-susceptible pulmonary TB (DS-PTB), and mortality predictors in drug-resistant TB (DR-TB), although several abstracts do not provide their final quantitative results [924][982][909].
Latent infection and progression to active disease
Tuberculosis preventive treatment (TPT) is intended to reduce progression from Mycobacterium tuberculosis infection or recent exposure to active TB. A systematic review and individual-participant meta-analysis evaluated the duration of TPT effectiveness among close contacts and people with evidence of infection across high-, medium-, and low-burden settings, using cohort studies and randomized trials published from 1998 through August 2023 [924]. The study specifically examined whether protection persists over time and whether its duration varies according to background TB burden; therefore, the durability of protection should not be assumed to be identical across epidemiological settings [924].
The available abstract does not report the pooled effect estimates or the exact duration of protection, so a precise time point at which TPT effectiveness ends cannot be stated from the supplied evidence [924]. Prognosis after LTBI also depends on host context. A prospective Chinese cohort followed participants for 10 years after baseline QuantiFERON-TB Gold In-Tube testing and evaluated cancer-specific, all-cause, and non-cancer mortality, but the supplied abstract does not report the corresponding associations between LTBI and mortality [1002].
Outcomes after treatment of drug-susceptible pulmonary TB
Standard DS-PTB management has conventionally used a 6-month multidrug regimen, but treatment shortening is being evaluated because longer treatment can compromise adherence [982]. A network meta-analysis of randomized trials in adolescents and adults compared standard 6-month therapy with rifamycin-intensified regimens, structurally modified 6-month regimens, 4-month approaches, and shorter intended regimens, with particular emphasis on long-term effectiveness and relapse control [982]. The abstract supplied here does not provide the comparative relapse estimates; consequently, shorter regimens should not be presumed equivalent to standard therapy solely on the basis of treatment duration [982].
Relapse remains a clinically important component of prognosis because apparent end-of-treatment success does not necessarily establish durable cure. Long-term follow-up and regimen architecture, rather than duration alone, are central to judging relapse prevention in DS-PTB [982].
Drug-resistant TB
DR-TB has substantial mortality despite improvements in diagnosis and treatment [909]. A systematic review and meta-analysis synthesized adjusted hazard ratios from longitudinal survival studies to identify prognostic factors for all-cause mortality among patients with any form of DR-TB; the supplied abstract confirms the scope and survival-analysis methodology but does not provide the pooled hazard ratios or rank individual predictors [909]. Therefore, the available evidence supports risk stratification as clinically important but does not permit a quantitative mortality estimate from this reference alone [909].
Programmatic outcomes may also underestimate or obscure prognosis when follow-up is incomplete. In a retrospective cohort of 417 DR-TB cases in Loreto, Peru, treated from 2015–2023, 49.5% had an unsuccessful outcome: 34.1% were lost to follow-up, 3.6% experienced treatment failure, and 11.8% died [1005]. In rural Eastern Cape, South Africa, routine DR-TB outcome data from 2020–2024 were interpreted as signals of both clinical performance and health-system governance because increasing proportions of outcomes were classified as “not evaluated” [991]. These findings indicate that reported treatment success rates may be strongly affected by ascertainment, retention, and data completeness [1005][991].
High-risk populations and modifiers of prognosis
Children living with HIV have particularly difficult diagnostic and prognostic pathways because microbiological confirmation is limited. An external-validation diagnostic cohort evaluated the PAANTHER treatment-decision algorithm in children aged 1 month to 14 years living with HIV across tertiary hospitals in Côte d’Ivoire, Mozambique, Uganda, and Zambia; the supplied abstract does not report its validation performance or mortality outcomes [1001].
Immunosuppression increases TB risk, and TPT is used in people receiving or preparing to start immunosuppressive medication. A systematic review and meta-analysis of 27 studies involving 3,184 participants evaluated adverse-event-related discontinuation by TPT regimen, but the supplied abstract does not provide pooled discontinuation estimates [999]. Pregnancy is another important clinical context: a Ugandan propensity-score-weighted cohort examined isoniazid monotherapy during pregnancy among women living with HIV and assessed miscarriage, stillbirth, low birth weight, neonatal complications, and maternal or neonatal death, but the supplied abstract does not report the adjusted outcome estimates [1003].
Active TB risk has also been studied in patients receiving immune-checkpoint inhibitors. A retrospective cohort reviewed 4,157 solid-tumor patients treated with checkpoint inhibitors and analyzed a subgroup of 118 patients with lung cancer who had LTBI, non-active TB, or previous TB; the supplied abstract does not provide the incidence or prognostic effect estimates [1008].
Interpretation of the wider evidence set
The remaining supplied studies address TB notification, missed video-observed-treatment sessions, intestinal TB presentation, anti-TB drug-induced liver-injury prediction, COVID-19 effects on TB services, and molecular or inflammatory mechanisms rather than directly measuring long-term TB prognosis [931][1004][966]C[926][1007][1006]. Studies of cabotegravir-rilpivirine, N-acetylcysteine, PD-1/PD-L1-associated cystitis, and Mycobacterium abscessus polyserositis are not evidence about the natural history of conventional M. tuberculosis disease [997][939][897]C[961]C.
| Clinical context | Prognostic implication | Evidence |
|---|---|---|
| LTBI or recent TB exposure | TPT protection is time-dependent and may vary by background TB burden; exact duration is not established in the supplied abstract. | [924] |
| DS-PTB after treatment | Relapse prevention must be evaluated by regimen and long-term follow-up, not treatment duration alone. | [982] |
| DR-TB | Mortality remains substantial; adjusted survival predictors were systematically reviewed. | [909] |
| DR-TB in Loreto, Peru | 49.5% unsuccessful outcomes; 34.1% loss to follow-up, 3.6% failure, and 11.8% death. | [1005] |
| DR-TB programme data | “Not evaluated” outcomes can limit interpretation of treatment success. | [991] |
Prevention and Infection Control
- ▸BCG remains the only licensed TB vaccine, with strongest established value against severe childhood TB; protection against pulmonary TB, infection, and transmission is variable or limited. [1004]
- ▸VPM1002 is an investigational recombinant BCG vaccine evaluated against BCG in newborns in a phase 3 African trial; comparative efficacy cannot be determined from the supplied abstract. [1004]
- ▸TST interpretation should be risk- and context-specific; relevant studied thresholds were **0–4 mm** for repeat testing after **1–4 weeks**, **≥10 mm** for entry into an adolescent risk-stratification analysis, and **≥15 mm** for additional stratification. [783,875]
- ▸Airborne isolation discontinuation should not rely on a single test result; GeneXpert-guided de-isolation has been compared with smear-guided practice, but no universal duration is established by the supplied evidence. [1001]
- ▸MDR-TB prevention requires targeted attention to demographic, clinical, socioeconomic, and behavioural risk profiles, particularly in sub-Saharan Africa. [867]
- ▸Transplant recipients, people with inborn errors of immunity, refugees, children with household exposure, and people living with HIV require tailored prevention or monitoring strategies. [752,764,783,868,936]
Vaccination and prevention of disease
BCG remains the only licensed tuberculosis (TB) vaccine, although protection against pulmonary TB in adolescents and adults is variable and protection against infection and transmission is limited or inconsistent. [1004] Its established preventive value is greatest for severe childhood TB, and vaccination should therefore remain an important component of infant immunisation programmes in high-burden settings. [1004] A community-based case-control study in rural Bangladesh specifically evaluated BCG protection against childhood TB among children aged 2–14 years in a marginalised tea-garden-worker population, while also assessing household exposure as a major prevention determinant. [936] The study demonstrates the importance of evaluating vaccination together with exposure-control measures, although the supplied evidence does not provide a quantitative vaccine-effect estimate. [936]
VPM1002, a recombinant BCG vaccine, was evaluated against BCG in a multicentre, double-blind, randomised phase 3 non-inferiority trial involving healthy newborn infants at sites across sub-Saharan Africa. [1004] The trial was designed to compare prevention of Mycobacterium tuberculosis infection in infants, addressing the limitations of conventional BCG protection against infection and transmission. [1004] No conclusion regarding comparative efficacy can be drawn from the available abstract alone. [1004] Experimental preventive approaches also include candidate vaccines evaluated in goats challenged with M. caprae; heat-inactivated M. bovis, phage-inactivated M. caprae, and live M. microti vaccines produced distinct immunological, pathological, and microbiological responses. [1007] These animal findings are investigational and should not be extrapolated to human TB prevention. [1007]
BCG is not established as a treatment for unrelated immune-mediated disease. [1002] A small double-blind randomised trial administered two BCG doses 4 weeks apart to adults with type 1 diabetes to assess glycaemic and immunological outcomes, rather than TB prevention. [1002] Similarly, a mouse study suggested that cholesterol 25-hydroxylase deficiency may enhance BCG-induced dendritic-cell activation and durable T-helper-1 immunity through the interleukin-12/interleukin-2 axis, but this remains preclinical evidence. [1006]
Screening for infection and disease
Screening should be adapted to the risk group, local epidemiology, vaccination background, and available diagnostic resources. [783]C[875] In adults with inborn errors of immunity, a proposed assessment included exposure history, symptom review, tuberculin skin testing (TST), and chest imaging with radiography or computed tomography when available. [783]C When the initial TST induration was 0–4 mm, the test was repeated after 1–4 weeks; this approach is relevant where an impaired or delayed response may produce an initially negative result. [783]C
In school screening in Hangzhou, China, investigators assessed whether a TST induration threshold of ≥15 mm added risk stratification among adolescents who already had induration of ≥10 mm, including routine screening, outbreak-contact, and previously cured-TB contexts. [875] Threshold interpretation is therefore context-dependent, particularly in populations with high BCG coverage, and should not be applied independently of exposure history, symptoms, prior TB, and local policy. [875]
Refugee health assessments should include review of TB risk, infectious-disease screening, and verification or catch-up of missing immunisations. [752] A retrospective cohort of Ukrainian paediatric refugees in Switzerland evaluated screening tests, vaccination status, and adherence to national guidance across five centres, illustrating the operational importance of structured reception screening when records are incomplete or fragmented. [752] Unvaccinated adolescents may be vulnerable to concurrent vaccine-preventable infections during TB illness; a reported case involved measles with extensive secondary pulmonary TB in an unvaccinated 17-year-old. [959]C
Healthcare infection control and isolation
Patients with suspected pulmonary TB should be managed using airborne-infection-control procedures while diagnostic evaluation is underway. [1001] A systematic review and meta-analysis compared GeneXpert MTB/RIF nucleic-acid amplification testing with acid-fast bacilli smear microscopy as a basis for discontinuing airborne isolation in hospitalised patients initially suspected of pulmonary TB. [1001] GeneXpert was assessed because of its greater diagnostic accuracy and operational convenience, but the available evidence summary does not provide a universal de-isolation duration or establish that a negative molecular test alone is sufficient in every clinical circumstance. [1001] De-isolation decisions should therefore incorporate the complete clinical, radiological, microbiological, and epidemiological assessment. [1001]
Prevention also requires attention to drug resistance and treatment adherence. A systematic review and meta-analysis of multidrug-resistant TB in sub-Saharan Africa examined demographic, clinical, socioeconomic, and behavioural characteristics associated with MDR-TB to inform targeted control strategies. [867] Kidney-transplant recipients in Africa represent another high-risk population because immunosuppression occurs in settings with high TB burden, endemic infections, resource constraints, and limited microbiological surveillance; the regional literature also identifies gaps in access to standard prophylactic strategies. [764]
Prevention during treatment and immune recovery
Patients with pulmonary TB may retain immune dysregulation during anti-TB therapy. [971] A nested subcohort from a phase IV multicentre randomised trial compared patients who had completed at least 3 months of treatment with healthy controls after inactivated COVID-19 vaccination, assessing humoral and systems-level multi-omic responses. [971] The study addresses whether apparently preserved antibody responses reflect coordinated immunity, but it does not establish a TB-prevention intervention. [971]
In people living with HIV, prevention includes coordinated TB treatment and antiretroviral management with vigilance for TB-associated immune reconstitution inflammatory syndrome (TB-IRIS). [868] In a low-incidence Italian cohort, TB-IRIS occurred in patients with HIV and TB, with disseminated TB and shorter intervals between TB-treatment initiation and antiretroviral therapy more frequent among affected patients. [868] Inflammatory markers may assist recognition, and one paradoxical case would have been missed by standard International Network for the Study of HIV-associated IRIS criteria. [868]
Anti-RBD antibody levels after SARS-CoV-2 vaccination or infection were studied in newly diagnosed TB patients during the first 2 months of treatment, but the available cohort evidence does not establish that these antibodies prevent TB or alter treatment outcomes. [841] Advanced pulmonary drug-delivery systems remain investigational for respiratory diseases; formulation stability, aerosol performance, lung clearance, and regulatory approval remain important barriers, so they should not yet be considered established TB-prevention tools. [1003]
| Prevention domain | Practical emphasis | Evidence |
|---|---|---|
| Infant vaccination | Continue BCG programmes; evaluate newer vaccines only within research or approved programmes | [1004][936] |
| Risk-based screening | Combine exposure history, symptoms, TST, and chest imaging; repeat very small TST reactions when clinically appropriate | [783]C |
| School or outbreak screening | Interpret ≥10 mm and ≥15 mm thresholds according to context, BCG coverage, and exposure setting | [875] |
| Hospital infection control | Use airborne precautions during evaluation and integrate GeneXpert, smear, clinical, and radiological findings before de-isolation | [1001] |
| High-risk populations | Tailor surveillance for refugees, transplant recipients, immunodeficiency, HIV, and household contacts | [752][764][783]C[868][936] |
| Drug resistance prevention | Use epidemiological and behavioural risk stratification to target MDR-TB control | [867] |
Special Hosts and Populations
- ▸Children have a greater risk of progression to TB disease than adults, and paediatric preventive-treatment evidence includes randomized trials in children and adolescents younger than 18 years without HIV. [923]
- ▸Stool-based Xpert MTB/RIF Ultra testing with centrifugation-free processing is an evaluated initial diagnostic strategy for children younger than 15 years. [905]
- ▸ART reduces but does not eliminate TB burden in PLHIV, and TPT implementation remains an important care-quality measure. [934, 940]
- ▸Pregnancy requires coordinated maternal, fetal, TB, and HIV care, with particular attention to TPT safety and drug pharmacokinetics. [972, 974, 1002]
- ▸Non-HIV immunocompromised patients may have atypical radiology and diagnostic delays; extrapulmonary, disseminated, and meningeal TB require early investigation and risk assessment. [1001, 1003, 1004]
Children and adolescents
Children and adolescents have a higher risk of progressing from tuberculosis (TB) infection to TB disease than adults, yet historically have been underrepresented in TB research. [923] In children and adolescents younger than 18 years with TB infection or documented contact with drug-susceptible TB, a systematic review and network meta-analysis evaluated the effectiveness and safety of available preventive-treatment regimens; the analysis included randomized controlled trials in participants without HIV and used updated searches through 12 December 2024. [923] Regimen selection should therefore consider age, drug susceptibility of the source case, adherence feasibility, hepatotoxicity risk, and local recommendations, while recognizing that the cited review specifically addressed children and adolescents without HIV. [923]
Paediatric TB diagnosis remains difficult because symptoms may be nonspecific, microbiological confirmation is often limited, and respiratory sampling can be invasive. [905] A multicentre prospective study in children younger than 15 years across South Africa, Tanzania, Malawi, Mozambique, and India evaluated a centrifugation-free Stool Processing Kit used with Xpert MTB/RIF Ultra; the study reflects the World Health Organization’s endorsement of stool-based molecular testing as an initial diagnostic approach for paediatric TB. [905] In children living with HIV, TB diagnosis is particularly challenging; a Kenyan cohort investigated antigen-specific antibody Fc-receptor engagement and IgA functional signatures as potential biomarkers that might distinguish TB disease and respond to treatment, but these biomarkers remain investigational rather than established routine tests. [1006] Childhood TB prevention is also influenced by vaccination and household exposure; a community-based case-control study of children aged 2–14 years in rural Bangladesh specifically evaluated BCG vaccination and household TB exposure in a marginalized tea-garden-worker population. [936]
People living with HIV
TB remains a major cause of morbidity and mortality among people living with HIV (PLHIV), even in the era of widespread antiretroviral therapy (ART). [996][940] A TB prevalence survey in Zambia and South Africa examined the excess TB prevalence among PLHIV receiving ART compared with the prevalence expected in an HIV-negative counterfactual population, emphasizing that ART reduces—but does not eliminate—the population burden of TB. [940] In South Africa, a retrospective analysis of 2005–2022 clinic data assessed whether preventive TB treatment (TPT) was prescribed within 6 months of ART initiation, after 6 months, or not recorded, addressing persistent gaps in TPT implementation. [934]
M72/AS01, a vaccine candidate previously associated with protection against active TB in HIV-negative adults, has been evaluated for safety in PLHIV receiving ART through a systematic review and meta-analysis of randomized trials; the review focused on adverse effects and immunocompromised-host tolerability, but the supplied evidence does not provide the pooled safety estimates. [996] Adolescents living with HIV may also require age-appropriate HIV-care models: the LATA trial enrolled virologically suppressed adolescents aged 12 to <20 years in Kenya, South Africa, Uganda, and Zimbabwe and compared eight-weekly long-acting injectable cabotegravir–rilpivirine with daily oral ART over 96 weeks. [997] This HIV-treatment evidence is relevant to continuity of care and does not itself establish a TB-specific treatment strategy. [997]
Pregnancy and postpartum care
Pregnancy complicates the diagnosis and management of TB because maternal disease may coexist with fetal and obstetric risks. [972]C A systematic review of reported cases of spinal TB in pregnancy, identified through October 2025, summarized maternal neurological and fetal outcomes, including reported live births and neurological recovery; the evidence consisted mainly of case reports and small series, so it cannot provide definitive comparative treatment guidance. [972]C
For pregnant women living with HIV, a Ugandan propensity-score-weighted analysis of routine-care data from 2016–2022 evaluated isoniazid monotherapy for TB prevention and a composite of miscarriage, stillbirth, low birth weight, neonatal complications, or maternal/neonatal death. [1002] The study addressed the safety of TPT during pregnancy in a high-burden setting, but the supplied abstract does not report the adjusted effect estimate. [1002] Pharmacokinetic considerations are also important: IMPAACT P1026s evaluated efavirenz exposure during the second and third trimesters and at 2–8 weeks postpartum in pregnant women living with HIV receiving efavirenz with rifampin and isoniazid, with or without ethambutol and pyrazinamide. [974]C These data directly address potential interactions between pregnancy-related pharmacokinetic changes, efavirenz, and first-line TB drugs. [974]C
Non-HIV immunocompromised and disseminated disease
TB in non-HIV immunocompromised patients may present atypically and may be diagnosed late. [1001] Compared with non-immunocompromised inpatients with liquid-culture-positive pulmonary TB, non-HIV immunocompromised patients had more bilateral lesions, pleural effusion, and lymphadenopathy but fewer cavities, and experienced longer health-system diagnostic delays; the study defined a long delay as >14 days from first medical contact to microbiological confirmation. [1001]
Extrapulmonary and disseminated TB can occur even without HIV or pharmacological immunosuppression. [1003] In a 23-year retrospective cohort, the gastrointestinal tract, lymph nodes, and genitourinary tract were the most commonly affected sites, while 24-month all-cause mortality was 18%; cardiovascular disease, central nervous-system involvement, mycobacteremia, and intensive-care admission were independently associated with death. [1003] A Chinese retrospective study of extrapulmonary TB from 2018–2025 evaluated epidemiological fluctuations, diagnostic yields of IGRA, Xpert MTB/RIF Ultra, and culture, and drug resistance including multidrug resistance, defined as resistance to at least isoniazid and rifampicin. [933] Tuberculous meningitis is especially severe: in a non-HIV cohort spanning children and adults, cumulative neurological complications documented during hospitalization and their association with in-hospital mortality were assessed. [1004]
Other vulnerable populations and service disruption
A Ghanaian study of 436 participants examined recurrent TB among PLHIV, informal miners, prisoners, rural poor people, smokers, and children, illustrating the heterogeneity of populations requiring intensified prevention and follow-up. [941] Community health workers remain important for linking marginalized communities to TB and HIV services; a Madagascar co-design initiative identified system constraints and developed the PROFESS support framework for community-health-worker engagement. [1005] Finally, a systematic review of low- and middle-income countries assessed how COVID-19 affected TB and HIV/AIDS service delivery and severity, using evidence published from 2019–8 January 2024; pandemic-related disruption should therefore be considered when interpreting missed diagnoses, delayed prevention, and interruptions in treatment. [1007]
| Population | Key considerations | Evidence |
|---|---|---|
| Children/adolescents | Higher progression risk; preventive-treatment evidence in those <18 years; stool molecular testing evaluated in those <15 years | [923][905] |
| PLHIV | Persistent TB burden despite ART; assess and implement TPT; vaccine safety evidence remains under evaluation | [934][940][996] |
| Pregnancy with HIV | Evaluate TPT safety and interactions involving rifampin, isoniazid, and efavirenz; monitor maternal and fetal outcomes | [974]C[1002] |
| Non-HIV immunocompromised patients | Atypical imaging, longer diagnostic delay, and need for broader differential diagnosis | [1001] |
| Extrapulmonary/disseminated TB | Consider multisite disease, CNS complications, drug resistance, and mortality risk | [933][1003][1004] |
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