Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea (NCT02015637) | Clinical Trial Compass
TerminatedPhase 3
Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea
United States460 participantsStarted 2014-01-23
Plain-language summary
The purpose of this study is to evaluate the effects of a single oral dose of delafloxacin versus a single intramuscular injection of ceftriaxone in subjects with uncomplicated cervical, urethral, rectal, or pharyngeal gonorrhea.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. gonorrhea with the nucleic acid amplification test (NAAT) or culture within the previous 14 days
. unprotected genital contact within 14 days with a person confirmed to be infected with gonorrhea,
. gram-negative present in urogenital gram strain or male subject must present with purulent urethritis or a female subject with must present with mucopurulent cervical discharge
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — do you know why it was stopped early, and does that affect how reliable the results are for deciding on a treatment approach?
2The trial was comparing delafloxacin to ceftriaxone for gonorrhea — is ceftriaxone still considered the standard treatment today, and how does that influence whether either drug studied here would be an option for me?
3Since this was a Phase 3 trial that didn't complete, is there enough safety and effectiveness data from it to inform my treatment, or should we be looking to other completed studies instead?
4Antibiotic resistance is a big concern with gonorrhea — based on what came out of this trial and other research, which antibiotic approach do you think gives me the best chance of a confirmed cure at follow-up?
5Are there currently approved or recommended treatments for uncomplicated gonorrhea that I should consider first, given that this trial was terminated and may not have produced full results?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population