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

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: Recruiting
• Conditions: Neisseria Gonorrheae Infection
• Intervention / Treatment: Diagnostic test: Investigational Reflex Test 1; Diagnostic test: Investigational Reflex Test 2; Diagnostic test: Investigational Reflex Test 3

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 (Estimated): 3291

Contacts and Locations

• Study Contact: Name: Nyssa Schwager, MSN, RN; Phone Number: 708-217-1146; Email: nyssa.schwager@duke.edu
• Study Contact Backup: Name: Michael J. Satlin, MD, MS; Phone Number: 434-531-6218; Email: mjs9012@med.cornell.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94102
      • Recruiting
      • San Francisco Public Health Laboratory
      • Contact: Lina Castro, PHM, MPH, M(ASCP)CM, TS (ABB); Phone Number: 415-554-2800; Email: lina.castro@sfdph.org
      • Contact: John Lei, Virology Supervisor; Phone Number: 415-554-2800; Email: john.lei@sfdph.org
      • Principal Investigator: Godfred Masinde, Laboratory Director
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University School of Medicine
      • Contact: Ann LeMonte; Phone Number: 317-274-5044; Email: alemonte@iu.edu
      • Contact: Paul Sparks; Phone Number: 317-278-4607; Email: pasparks@iu.edu
      • Principal Investigator: Aaron C Ermel
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • Mississippi State Department of Public Health
      • Contact: Whitney Roberts; Phone Number: 601-576-7973; Email: whitney.roberts@msdh.ms.gov
      • Contact: Terrika Flowers; Phone Number: 601-576-7973; Email: terrika.flowers1@msdh.ms.gov
      • Principal Investigator: Anna Scasny
  • Missouri
    • Royal Oak, Missouri, United States, 48073
      • Recruiting
      • Corewell Health
      • Principal Investigator: Carmen Demarco, MD
      • Contact: Maureen Cooney, RN, BSN, CCRP; Phone Number: 248-551-0027; Email: maureen.cooney@corewellhealth.org
      • Contact: Kimberly Powell; Phone Number: 248-551-2685; Email: kimberly.powell2@corewellhealth.org
      • Sub-Investigator: Matthew Sims, MD PhD, FACP, FIDSA
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Recruiting
      • LabCorp
      • Contact: Mary Hunt; Phone Number: 336-290-3191; Email: mary.hunt@labcorp.com
      • Contact: Ayla Burns; Phone Number: 336-436-2056; Email: burnsa2@labcorp.com
      • Principal Investigator: Susanne Dale, PhD, D(ABMM)
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Recruiting
      • ARUP Laboratories
      • Contact: Megan Hirschi, Research Manager; Phone Number: 6252 801-583-2787; Email: megan.hirschiadamson@aruplab.com
      • Principal Investigator: Salika Shakir, Ph.D., D(ABMM)
      • Contact: Jadyn Shoemaker, MB(ASCP); Phone Number: 801-583-2787; Email: jadyn.schoemaker@aruplab.com
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia School of Medicine
      • Contact: Melinda D Poulter, Ph.D., D (ABMM); Phone Number: 434-924-5667; Email: mdp3s@uvahealth.org
      • Contact: Emily Snavely, Ph.D., D(ABMM); Phone Number: 434-243-7401; Email: xjx4nh@uvahealth.org
      • Principal Investigator: Melinda D Poulter, Ph.D., D (ABMM)
      • Sub-Investigator: Emily Snavely, Ph.D., D(ABMM)
      • Sub-Investigator: Amy J Mathers, MD, D(ABMM)
  • Washington
    • Vancouver, Washington, United States, 98684
      • Recruiting
      • Molecular Testing Labs
      • Contact: Chris Hemphill; Phone Number: 360-693-8850; Email: chemphill@moleculartestinglabs.com
      • Principal Investigator: Charles Sailey

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

3

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	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	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	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	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	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	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	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	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	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	One day
Number of invalid results for Investigational Reflex Test 1 in vaginal swabs	One day
Number of invalid results for Investigational Reflex Test 1 in pharyngeal swabs	One day
Number of invalid results for Investigational Reflex Test 2 in urine	One day
Number of invalid results for Investigational Reflex Test 2 in vaginal swabs	One day
Number of invalid results for Investigational Reflex Test 2 in pharyngeal swabs	One day
Number of invalid results for Investigational Reflex Test 3 in urine	One day
Number of invalid results for Investigational Reflex Test 3 in vaginal swabs	One day
Number of invalid results for Investigational Reflex Test 3 in pharyngeal swabs	One day

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): April 16, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 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): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: mutant allele gyrA 91F; wildtype allele gyrA 91S; ciprofloxacin-resistant Neisseria gonorrhoeae
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Gonorrhea
• 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