512. Efficacy of Gepotidacin versus Nitrofurantoin in a Nitrofurantoin Not Susceptible Population: A Pooled Analysis of the EAGLE-2 and EAGLE-3 Randomized Controlled Trials in Uncomplicated Urinary Tract Infection
Abstract
Abstract Background Two Phase 3 trials (EAGLE-2 [NCT04020341]/EAGLE-3 [NCT04187144]) showed that gepotidacin, a first-in-class triazaacenaphthylene antibacterial, was non-inferior to nitrofurantoin (NTF) in treating uncomplicated urinary tract infection (uUTI) caused by NTF-susceptible (NTF-S) qualifying uropathogens (≥ 105 CFU/mL).1 This study evaluates gepotidacin efficacy in the pooled EAGLE-2/3 microbiological intent-to-treat (micro-ITT) NTF not susceptible (NTF-NS) population. Methods In EAGLE-2/3, female patients aged ≥ 12 years with ≥ 2 uUTI symptoms received oral gepotidacin (1500mg) or NTF (100mg) twice-daily for 5 days.1 In this study, therapeutic, clinical and microbiological response (defined in tables) at test-of-cure (Day 10–13) were assessed in the pooled EAGLE-2/3 micro-ITT NTF-NS and NTF-S populations and across patient subgroups. Results Of the 1421 micro-ITT patients, 220 (15%) had NTF-NS uropathogens and 1201 (85%) had NTF-S uropathogens. The most common baseline uropathogens were Escherichia coli (90%) in the NTF-S population, and Klebsiella pneumoniae (31%), Proteus mirabilis (26%), and E. coli (24%) in the NTF-NS population (Table 1). Across key subgroups, the proportion of patients with NTF-NS uropathogens was broadly similar to the overall population (except Hispanic/Latinx, Black race and US subgroups which were numerically higher; Figure 1). For efficacy outcomes, treatment differences were higher in the NTF-NS vs the NTF-S population, and, as…
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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.
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