Clinical trial NCT06815536: Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Official title: Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neisseria Gonorrheae Infection
Keywords: mutant allele gyrA 91F
wildtype allele gyrA 91S
ciprofloxacin-resistant Neisseria gonorrhoeae
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: SpeeDx Pty Ltd
name: Abbott
name: Seegene USA Inc
First posted: 2025-02-07
Enrollment: 3291
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical specimens from male and females that test positive for Neisseria gonorrhoeae

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urine
timeFrame: One day
measure: Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in vaginal swabs
timeFrame: One day
measure: Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in pharyngeal swabs
timeFrame: One day
measure: Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in urine
timeFrame: One day
measure: Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in vaginal swabs
timeFrame: One day
measure: Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in pharyngeal swabs
timeFrame: One day
measure: Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in urine
timeFrame: One day
measure: Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in vaginal swabs
timeFrame: One day
measure: Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in pharyngeal swabs
timeFrame: One day
Secondary outcomes:
measure: Number of invalid results for Investigational Reflex Test 1 in urine
timeFrame: One day
measure: Number of invalid results for Investigational Reflex Test 1 in vaginal swabs
timeFrame: One day
measure: Number of invalid results for Investigational Reflex Test 1 in pharyngeal swabs
timeFrame: One day
measure: Number of invalid results for Investigational Reflex Test 2 in urine
timeFrame: One day
measure: Number of invalid results for Investigational Reflex Test 2 in vaginal swabs
timeFrame: One day
measure: Number of invalid results for Investigational Reflex Test 2 in pharyngeal swabs
timeFrame: One day
measure: Number of invalid results for Investigational Reflex Test 3 in urine
timeFrame: One day
measure: Number of invalid results for Investigational Reflex Test 3 in vaginal swabs
timeFrame: One day
measure: Number of invalid results for Investigational Reflex Test 3 in pharyngeal swabs
timeFrame: One day
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Public Health Laboratory
state: California
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Jackson
country: United States
facility: Mississippi State Department of Public Health
state: Mississippi
city: Royal Oak
country: United States
facility: Corewell Health
state: Missouri
city: Durham
country: United States
facility: LabCorp
state: North Carolina
city: Salt Lake City
country: United States
facility: ARUP Laboratories
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia School of Medicine
state: Virginia
city: Vancouver
country: United States
facility: Molecular Testing Labs
state: Washington
Study officials:
affiliation: Weill Medical College of Cornell University
name: Michael J. Satlin, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California - Los Angeles
name: Jeffrey D. Klausner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Vance G. Fowler, MD, MHS
role: STUDY_DIRECTOR
References: