RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-16
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06815536

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be N. gonorrhoeae-positive on an FDA-cleared molecular assay
  2. * Have sufficient N. gonorrhoeae-positive specimen volume for testing using the corresponding investigational reflex test and genetic sequencing
  3. * Undergo proper handling and storage conditions
  1. * The N. gonorrhoeae-positive specimen media is not compatible with the investigational reflex test(s) at the laboratory site
  2. * The N. gonorrhoeae-positive specimen is not clearly labeled by the laboratory to link to basic epidemiologic data (age, sex) and source

Contacts and Locations

Study Contact

Nyssa Schwager, MSN, RN
CONTACT
708-217-1146
nyssa.schwager@duke.edu
Michael J. Satlin, MD, MS
CONTACT
434-531-6218
mjs9012@med.cornell.edu

Principal Investigator

Michael J. Satlin, MD, MS
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Jeffrey D. Klausner, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Southern California - Los Angeles
Vance G. Fowler, MD, MHS
STUDY_DIRECTOR
Duke University

Study Locations (Sites)

San Francisco Public Health Laboratory
San Francisco, California, 94102
United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202
United States
Mississippi State Department of Public Health
Jackson, Mississippi, 39216
United States
Corewell Health
Royal Oak, Missouri, 48073
United States
LabCorp
Durham, North Carolina, 27703
United States
ARUP Laboratories
Salt Lake City, Utah, 84108
United States
University of Virginia School of Medicine
Charlottesville, Virginia, 22908
United States
Molecular Testing Labs
Vancouver, Washington, 98684
United States

Collaborators and Investigators

Sponsor: Duke University

  • Michael J. Satlin, MD, MS, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University
  • Jeffrey D. Klausner, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Southern California - Los Angeles
  • Vance G. Fowler, MD, MHS, STUDY_DIRECTOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-16
Study Completion Date2026-02

Study Record Updates

Study Start Date2025-04-16
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • mutant allele gyrA 91F
  • wildtype allele gyrA 91S
  • ciprofloxacin-resistant Neisseria gonorrhoeae

Additional Relevant MeSH Terms

  • Neisseria Gonorrheae Infection