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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 weeks
Treatment ~ Varies
Follow Up ~day 6 and day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 6 and day 30 for reporting.

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 more

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).

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any short or long term dangers associated with zoliflodacin?

"Zoliflodacin safety is estimated to be a 3. This number comes from the fact that zoliflodacin is in Phase 3 of clinical trials."

Answered by AI

What infections does zoliflodacin typically kill?

"Zoliflodacin is a medication used to treat various infections, such as those located in the abdomen or caused by genus chlamydia. Additionally, it can be given to adult patients suffering from streptococcus agalactiae infection."

Answered by AI

Are there other zoliflodacin studies that have already been completed?

"Zoliflodacin was first trialled a decade ago at Copsac, DBAC. Since then, there have been 289 completed studies and presently 72 clinical trials are actively recruiting patients. A high concentration of these active trials are based in Indianapolis, Indiana."

Answered by AI

Are they currently looking for more participants in this trial?

"That is correct, the clinical trial listed on clinicaltrials.gov is currently recruiting patients. The posting dates of this particular trial are from 11/6/2019-11/7/2022 and they are looking for 1092 participants at 3 locations."

Answered by AI

How many people are currently being enrolled in this trial?

"Yes, this is an ongoing study that is still looking for enrolment from patients. The clinical trial was first posted on 11/6/2019 and the latest update was on 11/7/2022. They are expecting to have 1092 participants between 3 sites."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
< 18
What site did they apply to?
University of Alabama at Birmingham
Louisiana State University Health Sciences Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~202 spots leftby Apr 2025