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Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Sponsor: Duke University
Summary
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 Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
3291
Start Date
2025-04-16
Completion Date
2026-07
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Investigational Reflex Test 1
Investigational Reflex Test 1
Investigational Reflex Test 2
Investigational Reflex Test 2
Investigational Reflex Test 3
Investigational Reflex Test 3
Locations (8)
San Francisco Public Health Laboratory
San Francisco, California, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Mississippi State Department of Public Health
Jackson, Mississippi, United States
Corewell Health
Royal Oak, Missouri, United States
LabCorp
Durham, North Carolina, United States
ARUP Laboratories
Salt Lake City, Utah, United States
University of Virginia School of Medicine
Charlottesville, Virginia, United States
Molecular Testing Labs
Vancouver, Washington, United States