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NCT03867734 · ClinicalTrials.gov registry record · Phase 2
Aztreonam for Pharyngeal Gonorrhea
A Phase 2 study of Gonorrhea and Gonorrhea of Pharynx, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03867734: Completed Phase 2 study of Gonorrhea and Gonorrhea of Pharynx, sponsored by University of Washington.
NCT03867734 is a Phase 2 study of Gonorrhea and Gonorrhea of Pharynx that has completed, run by University of Washington. The registered enrollment target is 32 participants, below the 1,443-participant average among 10 other Gonorrhea trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03867734, a Phase 2 study of Gonorrhea and Gonorrhea of Pharynx, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
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 aztreonam 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 aztreonam appears to be \>98.6% efficacious for anogenital NG, its efficacy at the pharynx may be less. Only 8 cases of pharyngeal gonorrhea have been documented to be treated with aztreonam, but of those, only 5 (62.5%) were cured. The dose used in those studies was 1g of aztreonam. Most antibiotics have a lower efficacy at the pharynx than anogenital sites, which is likely due to drug pharmacokinetics, i.e. difficulty in penetrating pharyngeal tissue. Thus, in the proposed study, we plan to treat 50 subjects with untreated pharyngeal gonorrhea with 2g IM Aztreonam. Objectives: The proposed study aims to evaluate the efficacy of a single 2g intramuscular (IM) dose of aztreonam in the treatment of pharyngeal gonorrhea. Secondary objectives include documenting the efficacy stratified by minimal inhibitory concentration (MIC) compared with the previously document area under the curve (AUC) in order to estimate a pharmacodynamic criterion. We will also attempt to determine whether aztreonam monotherapy induces antimicrobial resistance among treatment failures. Lastly, we will evaluate th
Primary Outcome
Negative Test of Cure (i.e. Pharyngeal Gonorrhea Culture) after Treatment
Conditions Studied
Interventions
- DRUG Aztreonam
Study Locations (1)
Washington
- Public Health -- Seattle & King County STD Clinic - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-04-05 |
| Est. Completion | 2019-09-30 |
| Phase | Phase 2 |
What the finished NCT03867734 record still lists
NCT03867734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,443-participant average among 10 other Gonorrhea trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Gonorrhea appearing as the primary indexed condition, and to 1 intervention - of which Aztreonam is the first listed.
NCT03867734 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT03867734 about?
NCT03867734 is a clinical study titled "Aztreonam for Pharyngeal Gonorrhea". 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 NCT03867734?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2019-04-05. Estimated completion is 2019-09-30.
What conditions does trial NCT03867734 study?
This clinical trial studies the following conditions: Gonorrhea, Gonorrhea of Pharynx.
What interventions are being tested in trial NCT03867734?
The interventions under investigation include: Aztreonam (DRUG).
Who is sponsoring clinical trial NCT03867734?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03867734 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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