NCT03959527

Zoliflodacin in Uncomplicated Gonorrhoea

A Multi-center, Randomized, Open-label, Non Inferiority Trial to Evaluate the Efficacy and Safety of a Single, Oral Dose of Zoliflodacin Compared to a Combination of a Single Intramuscular Dose of Ceftriaxone and a Single Oral Dose of Azithromycin in the Treatment of Patients With Uncomplicated Gonorrhoea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,011 (actual)
• Sponsor: Global Antibiotics Research and Development Partnership · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated gonorrhoea.

Conditions

• Gonorrhea

Interventions

Type	Name	Description
DRUG	zoliflodacin	Dose: 3g, oral administration
DRUG	ceftriaxone	Dose: 500mg, Intra-Muscular (IM) administration
DRUG	azithromycin	Dose: 1g, oral administration

Timeline

• Start date: 2019-11-06
• Primary completion: 2023-08-30
• Completion: 2023-09-18
• First posted: 2019-05-22
• Last updated: 2025-10-08
• Results posted: 2024-07-26

Locations

17 sites across 5 countries: United States, Belgium, Netherlands, South Africa, Thailand

Regulatory

• FDA-regulated drug study