Gepotidacin safe and effective for treatment of uncomplicated urinary tract infections

1. Therapeutic response at days 10-13 was greater in the gepotidacin group compared to the nitrofurantoin group across both trials.

2. Gepotidacin use was associated with diarrhea as the most common adverse event and no significant fatalities were reported.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Urinary tract infections (UTIs) affect a large portion of women worldwide. While many antimicrobial treatment options exist, concerns regarding growing antibacterial resistance prompt a need for novel therapeutics. Gepotidacin, a bacterial DNA replication inhibitor, is a novel antibiotic that may be used for the treatment of uncomplicated UTIs, although limited evidence exists. This study of two randomized controlled trials (EAGLE-2 and EAGLE-3) aimed to assess the safety and efficacy of oral gepotidacin versus nitrofurantoin. The primary outcome of this study was therapeutic response (success or failure) at test-of-cure (day 10-13). According to study results, gepotidacin was non-inferior to nitrofurantoin in both studies and showed superiority in EAGLE-3. Additionally, gepotidacin was generally well tolerated with diarrhea being the most common adverse event. However, its inclusion criteria of patients with two or more characteristic symptoms may limit generalizability to those with more mild or unusual presentations.

Click to read the study in The Lancet

Relevant Reading: Efficacy and Safety of Gepotidacin as Treatment of Uncomplicated Urogenital Gonorrhea (EAGLE-1): Design of a Randomized, Comparator-Controlled, Phase 3 Study

In-depth [randomized-controlled trial]: Between Oct 17, 2019, and Dec 1, 2022, 2411 patients were screened for eligibility across two major trials (EAGLE-2 and EAGLE-3). Included were non-pregnant female patients ≥ 12 years old with symptoms of uncomplicated urinary tract infections and evidence of urinary nitrite or pyuria. Altogether, 3136 patients (767 in gepotidacin and 764 in nitrofurantoin for EAGLE-2, and 805 in gepotidacin and 800 in nitrofurantoin for EAGLE-3) were included in the final analysis. The primary outcome of therapeutic response at days 10-13 favored gepotidacin, showing higher success rates compared to nitrofurantoin in EAGLE-2 (50.6% vs. 47.0%) and EAGLE-3 (58.5% vs. 43.6%). The majority of adverse events were mild-to-moderate and there were no treatment-related fatalities. Overall, findings from this study suggest that gepotidacin is an effective oral antibiotic with potential benefits for patients with uncomplicated urinary tract infections.

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