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Antibiotic

Zoliflodacin for Gonorrhea

Phase 3
Waitlist Available
Research Sponsored by Global Antibiotics Research and Development Partnership
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 - 36 h
Awards & highlights
Approved for 30 Other Conditions
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing a new pill called zoliflodacin to see if it works as well as the current standard treatment for patients with uncomplicated gonorrhoea. The pill works by stopping the bacteria from growing, which helps to clear the infection. Zoliflodacin has shown promise in treating uncomplicated gonorrhea.

Eligible Conditions
  • Gonorrhea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 - 36 h
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 - 36 h for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Microbiological Cure Rate for Zoliflodacin Compared to a Combination of a Single Dose of Ceftriaxone and Azithromycin.
Secondary study objectives
Antimicrobial Susceptibility Profile Will be Determined of Gonococcal Strains Isolated From Participants With Uncomplicated Gonorrhoea at Baseline and the Test of Cure Visit.
Arithmetic Mean Plasma Concentration of Zoliflodacin
Evaluation of the Plasma PK Profile After a Single, Oral, 3 g Dose of Zoliflodacin
+9 more

Side effects data

From 2023 Phase 3 trial • 1011 Patients • NCT03959527
10%
Headache
7%
Neutropenia
4%
Leukopenia
3%
Neutrophil count decreased
3%
Nausea
3%
Dizziness
2%
Diarrhoea
1%
Injection site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zoliflodacin
Ceftriaxone and Azithromycin Combination

Awards & Highlights

Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: zoliflodacinExperimental Treatment1 Intervention
Participant in this arm will receive a single dose of zoliflodacin.
Group II: ceftriaxone and azithromycin combinationActive Control2 Interventions
Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zoliflodacin
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Global Antibiotics Research and Development PartnershipLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Azithromycin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03959527 — Phase 3
Gonorrhea Research Study Groups: ceftriaxone and azithromycin combination, zoliflodacin
Gonorrhea Clinical Trial 2023: Azithromycin Highlights & Side Effects. Trial Name: NCT03959527 — Phase 3
Azithromycin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03959527 — Phase 3
~168 spots leftby Nov 2025
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