Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Duke University
3,291 participants
Apr 16, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria2
- 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
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Interventions
Investigational Reflex Test 1
Investigational Reflex Test 2
Investigational Reflex Test 3
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT06815536