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Phase 3Completed

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

A Phase III, Randomized, Multicenter, Open-Label Study in Adolescent and Adult Participants Comparing the Efficacy and Safety of Gepotidacin to Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae

Sponsor
GlaxoSmithKline (Industry)
Enrollment
628 enrolled
Conditions
Gonorrhea
Interventions
Gepotidacin; Ceftriaxone; Azithromycin
Ages
children, adults, older adults
Registry
NCT04010539, EUCTR2018-001780-23

Full record on ClinicalTrials.gov

From the registry

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 (N. gonorrhoeae) in adolescent and adult participants. In this study, participants will be randomly assigned to receive either oral gepotidacin or IM ceftriaxone plus oral azithromycin.

Primary outcomes

  • Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8)

History

  1. Results first posted

  2. Last registry update

  3. Primary completion

  4. Started

  5. Registered

Papers citing this trial