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

Recruiting

• Conditions: Neisseria Gonorrheae Infection

• Registration Number: NCT06815536
• Lead Sponsor: Duke University

Brief 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.

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 Timeline

• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Study First Posted: 2025-02-07
• Status Verified: 2025-04
• Study Start: 2025-04-16
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3291

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urine	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.
Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in vaginal swabs	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.
Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in pharyngeal swabs	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.
Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in urine	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.
Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in vaginal swabs	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.
Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in pharyngeal swabs	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.
Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in urine	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.
Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in vaginal swabs	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.
Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in pharyngeal swabs	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

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