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Clinical trialNCT06815536RecruitingObservational

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

SponsorDuke UniversityEnrollment3,291Neisseria Gonorrheae Infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • San Francisco Public Health Laboratory

    San Francisco, California, United States

    Godfred Masinde, Laboratory Director
    Recruiting
  • Indiana University School of Medicine

    Indianapolis, Indiana, United States

    Aaron C Ermel
    Recruiting
  • Mississippi State Department of Public Health

    Jackson, Mississippi, United States

    Anna Scasny
    Recruiting
  • Corewell Health

    Royal Oak, Missouri, United States

    Carmen Demarco, MDMatthew Sims, MD PhD, FACP, FIDSA
    Recruiting
  • Labcorp

    Durham, North Carolina, United States

    Susanne Dale, PhD, D(ABMM)
    Recruiting
  • Arup Laboratories

    Salt Lake City, Utah, United States

    Salika Shakir, Ph.D., D(ABMM)
    Recruiting
  • University of Virginia School of Medicine

    Charlottesville, Virginia, United States

    Amy J Mathers, MD, D(ABMM)Emily Snavely, Ph.D., D(ABMM)Melinda D Poulter, Ph.D., D (ABMM)
    Recruiting
  • Molecular Testing Labs

    Vancouver, Washington, United States

    Charles Sailey
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
16 Apr 2025
Primary completion
31 Jul 2026
Completion
31 Jul 2026
Last update posted
5 Mar 2026
Registered enrollment
3,291
Registry id
NCT06815536
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.