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

Description

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

Neisseria Gonorrheae Infection

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Neisseria Gonorrheae Infection
Intervention / Treatment

-

Contacts and Locations

San Francisco

San Francisco Public Health Laboratory, San Francisco, California, United States, 94102

Indianapolis

Indiana University School of Medicine, Indianapolis, Indiana, United States, 46202

Jackson

Mississippi State Department of Public Health, Jackson, Mississippi, United States, 39216

Royal Oak

Corewell Health, Royal Oak, Missouri, United States, 48073

Durham

LabCorp, Durham, North Carolina, United States, 27703

Salt Lake City

ARUP Laboratories, Salt Lake City, Utah, United States, 84108

Charlottesville

University of Virginia School of Medicine, Charlottesville, Virginia, United States, 22908

Vancouver

Molecular Testing Labs, Vancouver, Washington, United States, 98684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Michael J. Satlin, MD, MS, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Jeffrey D. Klausner, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Southern California - Los Angeles

Vance G. Fowler, MD, MHS, STUDY_DIRECTOR, Duke University

Study Record Dates

2026-02