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RECRUITING
NCT06815536

Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae

Sponsor: Duke University

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

Investigational Reflex Test 1

Investigational Reflex Test 1

DIAGNOSTIC_TEST

Investigational Reflex Test 2

Investigational Reflex Test 2

DIAGNOSTIC_TEST

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