Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Recruiting
Observational Study
Neisseria Gonorrheae Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Sex
- Any
- Study type
- Observational
- Participants needed
- 3,291 (estimated)
- Sponsor
- Duke University · Other
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About This Trial
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 …
Trial Locations
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Eligibility 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:
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Contacts