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

RecruitingOBSERVATIONAL
Enrollment

3,291

Participants

Timeline

Start Date

April 16, 2025

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2026

Conditions
Neisseria Gonorrheae Infection
Interventions
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

Trial Locations (8)

22908

NOT_YET_RECRUITING

University of Virginia School of Medicine, Charlottesville

27703

NOT_YET_RECRUITING

LabCorp, Durham

39216

NOT_YET_RECRUITING

Mississippi State Department of Public Health, Jackson

46202

RECRUITING

Indiana University School of Medicine, Indianapolis

48073

NOT_YET_RECRUITING

Corewell Health, Royal Oak

84108

NOT_YET_RECRUITING

ARUP Laboratories, Salt Lake City

94102

RECRUITING

San Francisco Public Health Laboratory, San Francisco

98684

NOT_YET_RECRUITING

Molecular Testing Labs, Vancouver

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

SpeeDx Pty Ltd

INDUSTRY

collaborator

Abbott

INDUSTRY

collaborator

Seegene USA Inc

UNKNOWN

lead

Duke University

OTHER