JAMA network open · 2026
Gepotidacin and Early Symptom Improvement in Uncomplicated Urinary Tract Infection: A Nonrandomized Clinical Trial.
СтатьяМногоцентровое исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Ramírez Marcela, Gupta Kalpana, Díaz-Regañón Jazmín, Banerjee Rudrani, Bablani Jagriti, Powell Danielle, Hankinson Arlene, Janmohamed Salim
Аннотация
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.
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.