NCT06815536

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,291

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Apr 2025

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Apr 2025Jul 2026

First Submitted

Initial submission to the registry

February 3, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 16, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

February 3, 2025

Last Update Submit

March 4, 2026

Conditions

Neisseria Gonorrheae Infection

Keywords

mutant allele gyrA 91Fwildtype allele gyrA 91Sciprofloxacin-resistant Neisseria gonorrhoeae

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (3)

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 1Diagnostic Test: Investigational Reflex Test 2Diagnostic Test: 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 1Diagnostic Test: Investigational Reflex Test 2Diagnostic Test: 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 1Diagnostic Test: Investigational Reflex Test 2Diagnostic Test: Investigational Reflex Test 3

Interventions

Investigational Reflex Test 2DIAGNOSTIC_TEST

Investigational Reflex Test 2

Pharyngeal SwabsUrineVaginal Swab
Investigational Reflex Test 3DIAGNOSTIC_TEST

Investigational Reflex Test 3

Pharyngeal SwabsUrineVaginal Swab
Investigational Reflex Test 1DIAGNOSTIC_TEST

Investigational Reflex Test 1

Pharyngeal SwabsUrineVaginal Swab

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

San Francisco Public Health Laboratory

San Francisco, California, 94102, United States

RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

Mississippi State Department of Public Health

Jackson, Mississippi, 39216, United States

RECRUITING

Corewell Health

Royal Oak, Missouri, 48073, United States

RECRUITING

LabCorp

Durham, North Carolina, 27703, United States

RECRUITING

ARUP Laboratories

Salt Lake City, Utah, 84108, United States

RECRUITING

University of Virginia School of Medicine

Charlottesville, Virginia, 22908, United States

RECRUITING

Molecular Testing Labs

Vancouver, Washington, 98684, United States

RECRUITING

MeSH Terms

Conditions

Gonorrhea

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Michael J. Satlin, MD, MS

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • Jeffrey D. Klausner, MD, MPH

    University of Southern California - Los Angeles

    PRINCIPAL INVESTIGATOR

  • Vance G. Fowler, MD, MHS

    Duke University

    STUDY DIRECTOR

Central Study Contacts

Nyssa Schwager, MSN, RN

CONTACT

708-217-1146nyssa.schwager@duke.edu

Michael J. Satlin, MD, MS

CONTACT

434-531-6218mjs9012@med.cornell.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2025

First Posted

February 7, 2025

Study Start

April 16, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
IPD will be available after the primary publication date. There is not end date for the IPD availability.
Access Criteria
Only those who have applied to the ARLG and being approved will be able to access the data.
More information

Locations

US(8)