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

September 2, 2026 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multi-center, cross-sectional study using consecutive clinical specimens that are collected for routine clinical care and test positive for N. gonorrhoeae using an FDA-cleared molecular assay. The study evaluates the diagnostic accuracy of multiple investigational reflex tests to detect the mutant allele gyrA 91F that predicts ciprofloxacin resistance in N. gonorrhoeae, as compared to a reference standard of Sanger sequencing of the gyrA codon 91. Specimens will be tested via a reference standard of Sanger sequencing and one investigational reflex test. The target sample size is 311 urine specimens, 496 vaginal swab specimens, and 469 pharyngeal specimens, for each investigational reflex test.

Study Type

Observational

Enrollment (Actual)

2627

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94102
        • San Francisco Public Health Laboratory
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Mississippi State Department of Public Health
    • Missouri
      • Royal Oak, Missouri, United States, 48073
        • Corewell Health
    • North Carolina
      • Durham, North Carolina, United States, 27703
        • LabCorp
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • ARUP Laboratories
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia School of Medicine
    • Washington
      • Vancouver, Washington, United States, 98684
        • Molecular Testing Labs

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Clinical specimens from male and females that test positive for Neisseria gonorrhoeae

Description

Inclusion 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Urine
Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using urine samples.
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
Vaginal Swab
Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using vaginal swabs.
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
Pharyngeal Swabs
Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using pharyngeal swabs.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urine
Time Frame: One day

Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing.

Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in vaginal swabs
Time Frame: One day

Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing.

Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in pharyngeal swabs
Time Frame: One day

Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing.

Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in urine
Time Frame: One day

Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing.

Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in vaginal swabs
Time Frame: One day

Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing.

Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in pharyngeal swabs
Time Frame: One day

Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing.

Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in urine
Time Frame: One day

Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing.

Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in vaginal swabs
Time Frame: One day

Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing.

Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in pharyngeal swabs
Time Frame: One day

Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing.

Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
One day

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of invalid results for Investigational Reflex Test 1 in urine
Time Frame: One day
One day
Number of invalid results for Investigational Reflex Test 1 in vaginal swabs
Time Frame: One day
One day
Number of invalid results for Investigational Reflex Test 1 in pharyngeal swabs
Time Frame: One day
One day
Number of invalid results for Investigational Reflex Test 2 in urine
Time Frame: One day
One day
Number of invalid results for Investigational Reflex Test 2 in vaginal swabs
Time Frame: One day
One day
Number of invalid results for Investigational Reflex Test 2 in pharyngeal swabs
Time Frame: One day
One day
Number of invalid results for Investigational Reflex Test 3 in urine
Time Frame: One day
One day
Number of invalid results for Investigational Reflex Test 3 in vaginal swabs
Time Frame: One day
One day
Number of invalid results for Investigational Reflex Test 3 in pharyngeal swabs
Time Frame: One day
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Abbott
SpeeDx Pty Ltd
Seegene USA Inc

Investigators

  • Principal Investigator: Michael J. Satlin, MD, MS, Weill Medical College of Cornell University
  • Principal Investigator: Jeffrey D. Klausner, MD, MPH, University of Southern California - Los Angeles
  • Study Director: Vance G. Fowler, MD, MHS, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2025

Primary Completion (Actual)

July 31, 2026

Study Completion (Actual)

July 31, 2026

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00113379
  • UM1AI104681 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) including clinical specimen details, investigational testing results, and sequencing results can be shared with other researchers after primary publication. Investigators must apply to the Antibacterial Resistance Group for approval to receive and use the data. Investigators must comply with additional contractual and regulatory obligations.

IPD Sharing Time Frame

IPD will be available after the primary publication date. There is not end date for the IPD availability.

IPD Sharing Access Criteria

Only those who have applied to the ARLG and being approved will be able to access the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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