Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Eligible age
All ages
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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.
Sponsor: Duke University
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's recruiting
San Francisco
Indianapolis
Jackson
Royal Oak
Durham
Salt Lake City
Charlottesville
Vancouver
Source: ClinicalTrials.gov · NCT06815536 · last updated 2026-03-05