Subgroup Analysis of Pooled Phase 3 Efficacy Data From Two Randomized Trials of Gepotidacin Versus Nitrofurantoin in Uncomplicated Urinary Tract Infections (EAGLE-2 and EAGLE-3) Including Participants With Uropathogens Not-Susceptible to Nitrofurantoin.

In 30 seconds

This pooled subgroup analysis of two phase 3 randomized trials compared gepotidacin with nitrofurantoin in female participants aged ≥12 years with uncomplicated urinary tract infections. At test-of-cure, therapeutic success favored gepotidacin in participants with nitrofurantoin-susceptible uropathogens by 9.6% [4.1, 15.2], and in those with nitrofurantoin not-susceptible uropathogens by 20.8% [9.2, 32.4]. Gepotidacin success rates were generally similar to or higher than nitrofurantoin across prespecified subgroups associated with antimicrobial resistance risk.

Key findings

• Among participants with nitrofurantoin-susceptible uropathogens, therapeutic success favored gepotidacin by 9.6% [4.1, 15.2].
• Among participants with nitrofurantoin not-susceptible uropathogens, therapeutic success favored gepotidacin by 20.8% [9.2, 32.4].
• In the not-susceptible group, treatment differences favored gepotidacin for clinical success by 10.3% [-1.4, 22.1] and microbiological success by 20.7% [9.2, 32.3].
• Across prespecified subgroups at higher risk for resistant uropathogens, gepotidacin success rates were similar to or higher than nitrofurantoin.

Why it matters

Nitrofurantoin non-susceptibility can complicate treatment selection for uncomplicated urinary tract infection. These pooled trial results suggest gepotidacin may retain efficacy in this subgroup, with the largest reported therapeutic-success difference occurring among participants with non-susceptible uropathogens. The findings also provide subgroup evidence across several characteristics associated with resistance risk.

What to keep in mind

The subgroup response rates were descriptively summarized; the abstract does not report inferential testing for these subgroup comparisons.