RecruitingNCT06815536

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


Sponsor

Duke University

Enrollment

3,291 participants

Start Date

Apr 16, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Investigational Reflex Test 1, Investigational Reflex Test 2, and others for people with neisseria gonorrheae infection. The study is currently recruiting participants at 8 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTInvestigational Reflex Test 1

Investigational Reflex Test 1

DIAGNOSTIC_TESTInvestigational Reflex Test 2

Investigational Reflex Test 2

DIAGNOSTIC_TESTInvestigational 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

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NCT06815536


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