Overview

Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)

Status:
Recruiting

Trial end date:
2023-01-13

Target enrollment:

Participant gender:

Summary

Urinary tract infections (UTIs; acute cystitis) are very common, with approximately 11 percentage of women (>18 years of age) reporting at least 1 episode of acute cystitis per year. The purpose of this study to evaluate the therapeutic response (combined microbiological and clinical efficacy per participant) of oral gepotidacin compared to oral nitrofurantoin for acute cystitis in adolescent and adult female participants. In this study, participants will be randomly assigned in a 1:1 ratio to receive either oral gepotidacin or oral nitrofurantoin. The study will enroll approximately 2000 participants with uncomplicated UTI. The duration of the study will be approximately 28 days with 4 planned study visits.

Phase:

Phase 3

Details

Lead Sponsor:

GlaxoSmithKline

Treatments:

Nitrofurantoin