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Zoliflodacin in Uncomplicated Gonorrhoea

NCT03959527 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1011

Last updated 2025-10-08

Study results available
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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

DRUG

zoliflodacin

Dose: 3g, oral administration

DRUG

ceftriaxone

Dose: 500mg, Intra-Muscular (IM) administration

DRUG

azithromycin

Dose: 1g, oral administration

Sponsors & Collaborators

  • Global Antibiotics Research and Development Partnership

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-06
Primary Completion
2023-08-30
Completion
2023-09-18
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Netherlands
  • South Africa
  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03959527 on ClinicalTrials.gov