Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Recruiting now
Conditions studied: Neisseria Gonorrheae Infection
In brief
The goal of this study is to learn if a few investigational tests can correctly find the gene mutation (mutant allele gyrA 91F) that predicts ciprofloxacin resistance in clinical specimens that harbor Neisseria gonorrhoeae. The main question the study aims to answer: Can the investigational reflex test find the correct gene mutation (Neisseria gonorrhoeae gyrA 91F or gyrA 91S) as compared to the sequenced result? Specimens that are collected for routine clinical care and harbor Neisseria gonorrhoeae will be evaluated in this study.
Key facts
- Study ID
- NCT06815536
- Run by
- Duke University
- People needed
- 3291
- Starts
- 2025-04-16
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-03-05
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Be N. gonorrhoeae-positive on an FDA-cleared molecular assay
- Have sufficient N. gonorrhoeae-positive specimen volume for testing using the corresponding investigational reflex test and genetic sequencing
- Undergo proper handling and storage conditions
You may not qualify if…
- The N. gonorrhoeae-positive specimen media is not compatible with the investigational reflex test(s) at the laboratory site
- The N. gonorrhoeae-positive specimen is not clearly labeled by the laboratory to link to basic epidemiologic data (age, sex) and source
Where it is running
- San Francisco Public Health Laboratory — San Francisco, California, United States (enrolling)
- Indiana University School of Medicine — Indianapolis, Indiana, United States (enrolling)
- Mississippi State Department of Public Health — Jackson, Mississippi, United States (enrolling)
- Corewell Health — Royal Oak, Missouri, United States (enrolling)
- LabCorp — Durham, North Carolina, United States (enrolling)
- ARUP Laboratories — Salt Lake City, Utah, United States (enrolling)
- University of Virginia School of Medicine — Charlottesville, Virginia, United States (enrolling)
- Molecular Testing Labs — Vancouver, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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