ArticleContemporary clinical trials communications2025
Impact of updated regulatory guidelines on study results in contemporary uncomplicated urinary tract infection clinical trials and implications for trial conduct and drug development: a comparative analysis with EAGLE-2 and EAGLE-3.
Article in Contemporary clinical trials communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
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Abstract
Aim: To understand the impact of current regulatory guidance for non-inferiority, randomized controlled trials (RCTs) in uncomplicated urinary tract infection (uUTI) on efficacy outcomes. Methods: EAGLE-2 and EAGLE-3 were phase 3, non-inferiority RCTs of oral gepotidacin (1500 mg twice daily for 5 days) vs nitrofurantoin (100 mg BID for 5 days) in females with uUTI. The composite (clinical and microbiological) primary endpoint, therapeutic response (success or failure), was assessed at test-of-cure (day 10-13) in participants with nitrofurantoin-susceptible uropathogens (≥10 Results: Nitrofurantoin therapeutic success was substantially lower in EAGLE-2/-3 (47 %/44 %) than historic studies (61-94 %) using different endpoints. Clinical success rates based on "resolution or near resolution" of symptoms were: 78.3 %/77.2 % (EAGLE-2) and 75.7 %/75.3 % (EAGLE-3) for gepotidacin/nitrofurantoin, respectively. IACR rates were: 84.5 %/82.6 % (EAGLE-2) and 75.5 %/76.4 % (EAGLE-3) (post hoc analysis). Conclusion: Differences in primary endpoint success criteria need to be considered when comparing contemporary and historic uUTI RCTs.The trials are registered at Clinicaltrials.gov (EAGLE-2, NCT04020341; EAGLE-3, NCT04187144).
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