Overview

A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea

Status:
Recruiting

Trial end date:
2023-08-04

Target enrollment:

Participant gender:

Summary

This is a phase III, randomized, multicenter, open-label study which will be performed to evaluate efficacy and safety of oral Gepotidacin compared to intramuscular (IM) ceftriaxone plus oral azithromycin for the treatment of uncomplicated urogenital infection caused by Neisseria gonorrhoeae in adolescent and adult subjects. In this study, subjects will be randomly assigned to receive either oral gepotidacin or IM ceftriaxone plus oral azithromycin. Approximately 600 subjects will be randomized to receive study treatment. The duration of the study will be approximately 21 days.

Phase:

Phase 3

Details

Lead Sponsor:

GlaxoSmithKline

Treatments:

Azithromycin
Ceftriaxone