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NCT03632109 · ClinicalTrials.gov registry record · Phase 2
Gent for Pharyngeal Gonorrhea (GC)
A Phase 2 study, sponsored by University of Washington.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT03632109 is a Phase 2 study that was terminated before completion, run by University of Washington. The registered enrollment target is 13 participants.
The verdict
NCT03632109, a Phase 2 study, was terminated before completion, sponsored by University of Washington.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The Centers for Disease Control and Prevention has identified antimicrobial-resistant (AMR) Neisseria gonorrhoeae (NG) as one of the nation's top three urgent AMR threats. Since the advent of antibiotics in the 1930s, NG has developed resistance to every first-line antibiotic. Parenteral third-generation cephalosporins are now the only class of drug with consistent efficacy against NG. New therapies are urgently needed. Although some novel antimicrobials are under development, reevaluating older drugs is another option for quickly identifying additional treatments for gonorrhea. We propose a demonstration study to test a single dose of gentamicin for the treatment of pharyngeal gonorrhea. We chose to focus on pharyngeal gonorrhea because these infections are common, play an important role in fostering gonococcal resistance, and are harder to eradicate than genital infections. Although gentamicin is 91% efficacious for genital NG, its efficacy at the pharynx may be less since streptomycin, another aminoglycoside previously used to treat gonorrhea, was not effective for pharyngeal NG. It is unknown if streptomycin's poor efficacy is indicative of limitations of aminoglycosides as a class. We plan to enroll 60 men who have sex with men in a demonstration study to be conducted at the Seattle \& King County STD Clinic to test the efficacy of 360 mg of gentamicin given intramuscularly for pharyngeal gonorrhea. Secondary objectives include determining the ideal pharmacodynamic criterion (comparing in vitro minimal inhibitory concentrations (MIC) of NG to peak gentamicin serum levels), estimating resistance induction among treatment failures, and assessing the tolerability of 360 mg of IM gentamicin. Objectives The proposed study aims to evaluate the efficacy of a single intramuscular (IM) dose of gentamicin in the treatment of pharyngeal gonorrhea. Secondary objectives include documenting the efficacy stratified by minimal inhibitory concentration (MIC) compared with the
Interventions
- DRUG gentamicin 360mg IM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2018-09-17 |
| Est. Completion | 2019-03-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03632109
The ClinicalTrials.gov registry entry for NCT03632109 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which gentamicin 360mg IM is the first listed.
NCT03632109 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03632109 about?
NCT03632109 is a clinical study titled "Gent for Pharyngeal Gonorrhea (GC)". The Centers for Disease Control and Prevention has identified antimicrobial-resistant (AMR) Neisseria gonorrhoeae (NG) as one of the nation's top three urgent AMR threats. Since the advent of antibiotics in the 1930s, NG has developed resistance to every first-line antibiotic. Parenteral third-gener...
What is the current status of trial NCT03632109?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2018-09-17. Estimated completion is 2019-03-12.
What interventions are being tested in trial NCT03632109?
The interventions under investigation include: gentamicin 360mg IM (DRUG).
Who is sponsoring clinical trial NCT03632109?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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