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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
Pivotal Trial
Approved for 30 Other Conditions
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 - 36 h
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 - 36 h
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 moreSide effects data
From 2023 Phase 3 trial • 1011 Patients • NCT0395952710%
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
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received chemotherapy or radiation treatment within the past 30 days.You have a history of alcohol or drug abuse within the past year that could affect your ability to participate in the trial, according to the investigator's judgment.You have had a serious allergic reaction to certain types of antibiotics like cephalosporin, penicillin, or macrolides.You have a heart condition that can cause irregular heartbeats or a prolonged QT interval, which can be risky.The text states that the age requirement for enrollment is 12 years old or older, provided that the local regulations and ethics guidance allow for it.
Research Study Groups:
This trial has the following groups:- Group 1: ceftriaxone and azithromycin combination
- Group 2: zoliflodacin
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.