P31 Efficacy and safety of oral gepotidacin in the treatment of uncomplicated urinary tract infection: results of two randomized, multicentre Phase 3 trials (EAGLE-2 and EAGLE-3)
Abstract
Abstract Background Uncomplicated urinary tract infections (uUTIs) are among the most prevalent infections worldwide. Currently, treatments are limited by antimicrobial resistance and antibiotic allergy/intolerance. There is an unmet need for new oral antibiotics active against uropathogens resistant to current treatments. Gepotidacin is a novel, bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct mechanism of action and binding site and provides well-balanced inhibition of two Type II topoisomerase enzymes. Gepotidacin is under investigation for treatment of uUTI. Methods EAGLE-2 (NCT04020341) and EAGLE-3 (NCT04187144) were near-identical global Phase 3, randomized, parallel-group, double-blind, non-inferiority (10% margin) studies comparing the efficacy and safety of oral gepotidacin (1500 mg twice daily, 5 days) to nitrofurantoin (100 mg [Macrobid] twice daily, 5 days) for the treatment of uUTI. Eligible female patients were aged ≥12 years with ≥2 uUTI symptoms and urinary nitrite or pyuria (Figure 1). Per latest US FDA guidance, the primary endpoint, therapeutic response at test-of-cure (Days 10–13), was evaluated in patients with qualifying uropathogen(s) (≥105 cfu/mL) susceptible to nitrofurantoin. Therapeutic success was combined clinical success (complete resolution of symptoms) and microbiological success (reduction of uropathogen[s] to 50 years) and uUTI recurrence (non-recurrent infection or recurrent…
How strong is the evidence?
Evidence Hub reads this as a randomized trial. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 2,986 participants or records.
Read the paper
Related studies
- Horizontal gene transfer in the human gastrointestinal tract: potential spread of antibiotic resistance genes
- Mutation supply and relative fitness shape the genotypes of ciprofloxacin-resistant Escherichia coli
- Genomic Survey of E. coli From the Bladders of Women With and Without Lower Urinary Tract Symptoms
- Characterization of cefotaxime-resistant urinary Escherichia coli from primary care in South-West England 2017–18
- Fitness cost constrains the spectrum of marR mutations in ciprofloxacin-resistant Escherichia coli
- Emerging evidence-based innovative approaches to control catheter-associated urinary tract infection: a review
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.