At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,011 enrolled
Drug / intervention
zoliflodacin +2 moredrug
Likely dose
zoliflodacin 3gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Global Antibiotics Research and Development Partnership·interventional·Posted May 22, 2019·Updated Oct 8, 2025
In Brief
A Phase 3 clinical trial evaluating zoliflodacin, ceftriaxone, and 1 other intervention for Gonorrhea. Completed, enrolled 1,011 participants across 17 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGonorrhea
CountriesBelgium, Netherlands, South Africa, Thailand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartNov 2019
Primary CompletionAug 2023
Study CompletionSep 2023
TodayJul 2026
First PostedMay 22, 2019
Enrollment StartNov 6, 2019
Primary CompletionAug 30, 2023
Study CompletionSep 18, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.1 years ago
Interventions
zoliflodacindrug
Dose: 3g, oral administration
ceftriaxonedrug
Dose: 500mg, Intra-Muscular (IM) administration
azithromycindrug
Dose: 1g, oral administration