Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Purpose
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.
Condition
- Neisseria Gonorrheae Infection
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Urine | Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using urine samples. |
|
| Vaginal Swab | Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using vaginal swabs. |
|
| Pharyngeal Swabs | Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using pharyngeal swabs. |
|
Recruiting Locations
San Francisco, California 94102
Indianapolis, Indiana 46202
Jackson, Mississippi 39216
Royal Oak, Missouri 48073
Salt Lake City, Utah 84108
Charlottesville, Virginia 22908
Vancouver, Washington 98684
More Details
- Status
- Recruiting
- Sponsor
- Duke University
Detailed Description
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.