Actively Recruiting
Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Led by Duke University · Updated on 2026-03-05
3291
Participants Needed
8
Research Sites
63 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
San Francisco Public Health Laboratory
San Francisco, California, United States, 94102
Actively Recruiting
2
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
Mississippi State Department of Public Health
Jackson, Mississippi, United States, 39216
Actively Recruiting
4
Corewell Health
Royal Oak, Missouri, United States, 48073
Actively Recruiting
5
LabCorp
Durham, North Carolina, United States, 27703
Actively Recruiting
6
ARUP Laboratories
Salt Lake City, Utah, United States, 84108
Actively Recruiting
7
University of Virginia School of Medicine
Charlottesville, Virginia, United States, 22908
Actively Recruiting
8
Molecular Testing Labs
Vancouver, Washington, United States, 98684
Actively Recruiting
Research Team
N
Nyssa Schwager, MSN, RN
CONTACT
M
Michael J. Satlin, MD, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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