Summary

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• This summary is based on the review of one randomized controlled trial. ^[1]
• In the Efficacy of Gepotidacin for the Treatment of Uncomplicated Urinary Tract Infections (EAGLE-2) trial of non-pregnant patients assigned female at birth aged 12 years or older with uncomplicated urinary tract infections (uUTIs), gepotidacin achieved a therapeutic success rate of 50.6% (162 out of 320 participants) compared to 47.0% (135 out of 287 participants) for nitrofurantoin; the adjusted difference was 4.3% (95% confidence interval [CI] -3.6 to 12.1), indicating non-inferiority.
• In the EAGLE-3 trial within the same population, gepotidacin showed a therapeutic success rate of 58.5% (162/277) versus 43.6% (115/264) for nitrofurantoin; the adjusted difference was 14.6% (95% CI 6.4 to 22.8), demonstrating superiority.
• The studies included non-pregnant individuals assigned female at birth, aged ≥12 years and ≥40 kg, with no subgroup-specific effectiveness outcomes reported.
• In the EAGLE-2 trial, the most common adverse event with gepotidacin was diarrhea (14%, 111/766), while the most common with nitrofurantoin was nausea (4%, 29/760); no life-threatening or fatal events were reported, and adverse events were mostly mild or moderate.
• In the EAGLE-3 trial, the most common adverse event with gepotidacin was diarrhea (18%, 147/804), while the most common with nitrofurantoin was nausea (4%, 35/798); no life-threatening or fatal events were reported, and adverse events were mostly mild or moderate.
• The studies included non-pregnant females aged ≥12 years with uncomplicated urinary tract infections who presented with ≥2 symptoms (e.g., dysuria, frequency, urgency, or lower abdominal pain) and evidence of urinary nitrite, pyuria, or both; although randomization was stratified by age category and history of recurrent infections, no subgroup-specific effectiveness or safety outcomes were reported.