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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

3291 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-16

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae

NCT02961751

Gonococcal Infection

COMPLETED NA

Experimental Human Infection With Neisseria Gonorrhoeae

NCT03840811

Gonococcal Infection

COMPLETED PHASE1

Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)

NCT04870138

Gonococcal Infection

COMPLETED PHASE1

A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea

NCT04010539

Gonorrhea

COMPLETED PHASE3

Antimicrobial Susceptibility Patterns of N. Gonorrhea Isolates in an Era of Quinolone Resistance

NCT00692822

Gonorrhea

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective, multi-center, cross-sectional study using consecutive clinical specimens that are collected for routine clinical care and test positive for N. gonorrhoeae using an FDA-cleared molecular assay. The study evaluates the diagnostic accuracy of multiple investigational reflex tests to detect the mutant allele gyrA 91F that predicts ciprofloxacin resistance in N. gonorrhoeae, as compared to a reference standard of Sanger sequencing of the gyrA codon 91. Specimens will be tested via a reference standard of Sanger sequencing and one investigational reflex test. The target sample size is 311 urine specimens, 496 vaginal swab specimens, and 469 pharyngeal specimens, for each investigational reflex test.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neisseria Gonorrheae Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Urine

Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using urine samples.