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

NCT06815536 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3291

Last updated 2026-03-05

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • SpeeDx Pty Ltd

    collaborator INDUSTRY

  • Abbott

    collaborator INDUSTRY

  • Seegene USA Inc

    collaborator UNKNOWN

  • Duke University

    lead OTHER

Principal Investigators

  • Michael J. Satlin, MD, MS · Weill Medical College of Cornell University

  • Jeffrey D. Klausner, MD, MPH · University of Southern California - Los Angeles

  • Vance G. Fowler, MD, MHS · Duke University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-16
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06815536 on ClinicalTrials.gov