Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06815536 · ClinicalTrials.gov registry record
Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
A clinical trial of Neisseria Gonorrheae Infection, sponsored by Duke University.
- Recruiting
- Registry status
- 3,291
- Enrollment target
- 8
- Study locations
NCT06815536: Recruiting study of Neisseria Gonorrheae Infection, sponsored by Duke University.
NCT06815536 is a study of Neisseria Gonorrheae Infection that is actively recruiting participants, run by Duke University. The registered enrollment target is 3,291 participants. The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06815536, a study of Neisseria Gonorrheae Infection, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- 3,291 participants
- Enrollment target
- 8
- Study locations
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.
Primary Outcome
Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Investigational Reflex Test 1
- DIAGNOSTIC_TEST Investigational Reflex Test 2
- DIAGNOSTIC_TEST Investigational Reflex Test 3
Study Locations (8)
California
- San Francisco Public Health Laboratory - San Francisco
Indiana
- Indiana University School of Medicine - Indianapolis
Mississippi
- Mississippi State Department of Public Health - Jackson
Missouri
- Corewell Health - Royal Oak
North Carolina
- LabCorp - Durham
Utah
- ARUP Laboratories - Salt Lake City
Virginia
- University of Virginia School of Medicine - Charlottesville
Washington
- Molecular Testing Labs - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,291 participants |
| Start Date | 2025-04-16 |
| Est. Completion | 2026-07 |
What NCT06815536 shows while recruiting
NCT06815536 is an observational study that tracks outcomes without assigning an intervention. Its 3,291 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Neisseria Gonorrheae Infection appearing as the primary indexed condition, and to 3 interventions - of which Investigational Reflex Test 1 is the first listed.
NCT06815536 lists 8 locations in 8 states (California, Indiana, Mississippi).
Frequently Asked Questions
What is clinical trial NCT06815536 about?
NCT06815536 is a clinical study titled "Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae". 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 ...
What is the current status of trial NCT06815536?
This trial is currently recruiting. The enrollment target is 3,291 participants. The study started on 2025-04-16. Estimated completion is 2026-07.
What conditions does trial NCT06815536 study?
This clinical trial studies the following conditions: Neisseria Gonorrheae Infection.
What interventions are being tested in trial NCT06815536?
The interventions under investigation include: Investigational Reflex Test 1 (DIAGNOSTIC_TEST), Investigational Reflex Test 2 (DIAGNOSTIC_TEST), Investigational Reflex Test 3 (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06815536?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06815536 being conducted?
This trial has 8 study locations across California, Indiana, Mississippi, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neisseria Gonorrheae Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06543446 · 3,290 participants · NA
Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy
- NCT07214610 · 3,300 participants · NA
Integrating Biological, Clinical, and Behavioral Factors to Improve Breast Cancer Outcomes - Carolina Breast Cancer Study
- NCT03674307 · 3,306 participants · NA
Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates
- NCT04077762 · 3,266 participants · NA
Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI