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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 day 6 and day 30
Awards & highlights
Study Summary
This trial is testing whether a new oral drug for gonorrhea is as effective and safe as the current standard treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 6 and day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 6 and day 30
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of a single dose of zoliflodacin will be assessed compared to a combination of a single dose of ceftriaxone and azithromycin.
Secondary outcome measures
Antimicrobial susceptibility profile will be determined of gonococcal strains isolated from participants with uncomplicated gonorrhoea at baseline and the test of cure visit.
Microbiological cure rate of Neisseria gonorrhoeae (NG) at urogenital sites will be determined.
Microbiological cure rate of pharyngeal gonorrhoea will be determined after administration of a single dose of zoliflodacin compared to a combination of a single dose of ceftriaxone and azithromycin.
+6 moreTrial 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).
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Who is running the clinical trial?
Global Antibiotics Research and Development PartnershipLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
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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:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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.
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