Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Public ClinicalTrials.gov record NCT06815536. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06815536
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 2,627 participants
Conditions and interventions
Conditions
Interventions
- Investigational Reflex Test 1 Diagnostic Test
- Investigational Reflex Test 2 Diagnostic Test
- Investigational Reflex Test 3 Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 16, 2025 (Actual)
- Primary completion
- Jul 31, 2026 (Actual)
- Completion
- Jul 31, 2026 (Actual)
- Last update posted
- Sep 3, 2026
2025 – 2026
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| San Francisco Public Health Laboratory | San Francisco | California | 94102 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| Mississippi State Department of Public Health | Jackson | Mississippi | 39216 | — |
| Corewell Health | Royal Oak | Missouri | 48073 | — |
| LabCorp | Durham | North Carolina | 27703 | — |
| ARUP Laboratories | Salt Lake City | Utah | 84108 | — |
| University of Virginia School of Medicine | Charlottesville | Virginia | 22908 | — |
| Molecular Testing Labs | Vancouver | Washington | 98684 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06815536, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 3, 2026 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06815536 live on ClinicalTrials.gov.