Early Symptom Response in Patients With Uncomplicated Urinary Tract Infection Treated With Gepotidacin or Nitrofurantoin: Pooled Analysis From Two Pivotal Phase 3 Studies
Abstract
Background: Uncomplicated urinary tract infections (uUTIs) can cause distressing symptoms seriously impacting daily activities. Early symptom relief during treatment, though fundamental to patients, is often overlooked in clinical trials. Gepotidacin, a new antibacterial agent, was noninferior to the first-line treatment nitrofurantoin in two randomized controlled trials (EAGLE-2 [NCT04020341] and EAGLE-3 [NCT04187144]). The current analysis utilized pooled data from these two trials to evaluate symptom responses during and after treatment in participants with uUTI.
Methods: Participants were aged ≥12 years with at least two uUTI symptoms, urinary nitrite and/or pyuria, and no complicating factors. Participants were randomized 1:1 to oral gepotidacin (1500 mg) or nitrofurantoin (100 mg), both taken twice daily for 5 days. At baseline (Day 1), on-therapy (OT; Days 2-4), and test-of-cure (TOC; Days 10-13) visits, urinary symptoms were assessed (0-3; none-severe) from which a total score (0-12) was derived.
Results: Overall, 3136 participants were randomized (1572 gepotidacin, 1564 nitrofurantoin). Mean (median) baseline symptom scores for gepotidacin and nitrofurantoin arms were 7.1 (7.0) and 7.2 (7.0), respectively; at OT, this decreased to 3.6 (3.0) for both arms. At the OT visit, >80% of participants had clinical improvement/resolution. Among those with baseline symptoms affecting everyday activities (moderate or severe), 53.2% (728/1369) assigned gepotidacin and 53.6%…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 3,136 participants or records.
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