Evaluating tests for detecting drug-resistant gonorrhea
Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
This study is testing new ways to see if certain tests can accurately find a gene that makes gonorrhea resistant to a common antibiotic in samples from patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3291 (estimated) |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 8 sites (San Francisco, California and 7 other locations) |
| Trial ID | NCT06815536 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the accuracy of several investigational tests in identifying a specific gene mutation (gyrA 91F) that indicates ciprofloxacin resistance in Neisseria gonorrhoeae. The study will utilize clinical specimens collected during routine care that test positive for N. gonorrhoeae using FDA-cleared molecular assays. A total of 311 urine, 496 vaginal swab, and 469 pharyngeal specimens will be analyzed using both the investigational tests and a reference standard of Sanger sequencing. The goal is to determine if these tests can reliably detect the mutation compared to the sequencing results.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who test positive for Neisseria gonorrhoeae and have sufficient specimen volume for testing.
Not a fit: Patients whose specimens are not compatible with the investigational tests or lack proper labeling for epidemiologic data may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for identifying drug-resistant gonorrhea, allowing for more effective treatment options.
How similar studies have performed: Other studies have shown promise in using genetic testing for identifying drug resistance in bacterial infections, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be N. gonorrhoeae-positive on an FDA-cleared molecular assay * Have sufficient N. gonorrhoeae-positive specimen volume for testing using the corresponding investigational reflex test and genetic sequencing * Undergo proper handling and storage conditions Exclusion Criteria: * The N. gonorrhoeae-positive specimen media is not compatible with the investigational reflex test(s) at the laboratory site * The N. gonorrhoeae-positive specimen is not clearly labeled by the laboratory to link to basic epidemiologic data (age, sex) and source
Where this trial is running
San Francisco, California and 7 other locations
- San Francisco Public Health Laboratory — San Francisco, California, United States (Recruiting)
- Indiana University School of Medicine — Indianapolis, Indiana, United States (Recruiting)
- Mississippi State Department of Public Health — Jackson, Mississippi, United States (Recruiting)
- Corewell Health — Royal Oak, Missouri, United States (Recruiting)
- LabCorp — Durham, North Carolina, United States (Recruiting)
- ARUP Laboratories — Salt Lake City, Utah, United States (Recruiting)
- University of Virginia School of Medicine — Charlottesville, Virginia, United States (Recruiting)
- Molecular Testing Labs — Vancouver, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Michael J. Satlin, MD, MS — Weill Medical College of Cornell University
- Study coordinator: Nyssa Schwager, MSN, RN
- Email: nyssa.schwager@duke.edu
- Phone: 708-217-1146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.