Gepotidacin and Early Symptom Improvement in Uncomplicated Urinary Tract Infection: A Nonrandomized Clinical Trial
In brief
Gepotidacin improved UTI symptoms within 24 hours in about half of women
In this single-arm trial, 54% of women had some symptom improvement by 24 hours, rising to about 80% by 48 hours; 90% had symptoms resolve by day 10. Most reported adverse events were mild or moderate, with none serious, but without a comparison group the study cannot show how gepotidacin's early effects compare with other treatments.
- Journal
- JAMA network open (Q1)
- Published
- 1 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Marcela Ramírez, Kalpana Gupta, Jazmín Díaz-Regañón, Rudrani Banerjee, Jagriti Bablani, Danielle Powell, et al.
- PMID
- 42809288
- DOI
- 10.1001/jamanetworkopen.2026.34116
Why clinicians should know about it
- Picked for Urology (top studies of the week, 4 October 2026): Early symptom improvement with gepotidacin in uUTI
Abstract
IMPORTANCE: Uncomplicated urinary tract infections (uUTIs) are common infections in women, and symptoms negatively impact patients' quality of life. Rapid symptom improvement is a high priority for patients and health care practitioners; however, few studies describe the early clinical effects of treatment. OBJECTIVE: To evaluate clinical symptom improvement daily from 24 hours until end of gepotidacin treatment (96 hours) and on day 10 in females with uUTIs. DESIGN, SETTING, AND PARTICIPANTS: This phase 3b, open-label, single-arm, multicenter nonrandomized clinical trial (October 2, 2024, to March 10, 2025) screened females (aged ≥12 years) with 2 or more uUTI symptoms and urinary nitrites or pyuria at 21 US sites. INTERVENTION: Oral gepotidacin (1500 mg) twice daily for 5 days. MAIN OUTCOMES AND MEASURES: The primary outcome was clinical symptom improvement (decrease in total clinical symptom score [CSS] of ≥1 from baseline without other systemic antimicrobials, with or without resolution) at 24 (±4) hours after treatment initiation. Secondary outcomes were clinical symptom improvement at 48, 72, and 96 (all ±4) hours after treatment initiation, clinical symptom resolution (reduction in total CSS to 0 without other systemic antimicrobials) at 24, 48, 72, and 96 (all ±4) hours after treatment initiation, and safety. Exploratory outcome was clinical symptom improvement and resolution at day 10 (+3 days). RESULTS: Overall, 103 females were evaluated, with 97 enrolling, 96 completing the study, 93 completing the study treatment, and 90 (mean [SD] age, 46.1 [16.4] years) included in the clinically evaluable population for the primary outcome. At 24 hours, 49 participants (54.4%; 95% CI, 43.6%-65.0%) in the clinically evaluable population had clinical symptom improvement. The number of participants with clinical symptom improvement at 48, 72, and 96 hours was 71 of 89 (79.8%; 95% CI, 69.9%-87.6%), 81 of 90 (90.0%; 95% CI, 81.9%-95.3%), and 77 of 89 (86.5%; 95% CI, 77.6%-92.8%), respectively. Clinical symptom resolution increased from 3 of 90 patients (3.3%) at 24 hours to 81 of 90 (90.0%) at day 10. Fifty-eight adverse events, mostly mild or moderate, were reported in 27 participants from the safety population. There were no serious adverse events. CONCLUSIONS AND RELEVANCE: In this phase 3b nonrandomized clinical trial, female participants with uUTIs experienced a rapid clinical response to gepotidacin as early as 24 hours after treatment initiation. These data may aid informed decision-making in the use of gepotidacin for treating uUTIs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06597344.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.