Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Duke University
- Study ID
- NCT06815536
- Status
- Recruiting
Conditions
- Neisseria Gonorrheae Infection
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Investigational Reflex Test 1 — DIAGNOSTIC_TESTInvestigational Reflex Test 1
- Investigational Reflex Test 2 — DIAGNOSTIC_TESTInvestigational Reflex Test 2
- Investigational Reflex Test 3 — DIAGNOSTIC_TESTInvestigational Reflex Test 3
Study Details
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 Dates
- Start date
- Apr 16, 2025
- Status verified
- Mar 2026
- Primary completion
- Jul 31, 2026
- Completion
- Jul 31, 2026
Study Design
- Enrollment
- 3,291 participants (estimated)
Arms
- Arm: UrineInvestigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using urine samples.
- Arm: Vaginal SwabInvestigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using vaginal swabs.
- Arm: Pharyngeal SwabsInvestigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using pharyngeal swabs.
Primary Outcome Measure
Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urine [ Time Frame: One day ]
Central Contacts
- Nyssa Schwager, MSN, RN708-217-1146
- Michael J. Satlin, MD, MS434-531-6218
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| San Francisco Public Health Laboratory | San Francisco | California | 94102 | Godfred Masinde, Laboratory Director (PRINCIPAL_INVESTIGATOR) |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | Aaron C Ermel (PRINCIPAL_INVESTIGATOR) |
| Mississippi State Department of Public Health | Jackson | Mississippi | 39216 | Anna Scasny (PRINCIPAL_INVESTIGATOR) |
| Corewell Health | Royal Oak | Missouri | 48073 | Carmen Demarco, MD (PRINCIPAL_INVESTIGATOR) Matthew Sims, MD PhD, FACP, FIDSA (SUB_INVESTIGATOR) |
| LabCorp | Durham | North Carolina | 27703 | Susanne Dale, PhD, D(ABMM) (PRINCIPAL_INVESTIGATOR) |
| ARUP Laboratories | Salt Lake City | Utah | 84108 | Salika Shakir, Ph.D., D(ABMM) (PRINCIPAL_INVESTIGATOR) |
| University of Virginia School of Medicine | Charlottesville | Virginia | 22908 | Melinda D Poulter, Ph.D., D (ABMM) (PRINCIPAL_INVESTIGATOR) Emily Snavely, Ph.D., D(ABMM) (SUB_INVESTIGATOR) Amy J Mathers, MD, D(ABMM) (SUB_INVESTIGATOR) |
| Molecular Testing Labs | Vancouver | Washington | 98684 | Charles Sailey (PRINCIPAL_INVESTIGATOR) |
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