Study of New Tests to Detect Ciprofloxacin-Resistant Neisseria Gonorrhoeae in Urine and Swab Samples

What this Trial Is About

Researchers are evaluating several investigational tests designed to detect a specific gene mutation called gyrA 91F in Neisseria gonorrhoeae, which predicts resistance to the antibiotic ciprofloxacin. This study aims to determine if these reflex tests can accurately identify this mutation compared to the standard Sanger sequencing method. The study involves clinical specimens that test positive for Neisseria gonorrhoeae from routine care. The study uses multiple investigational reflex tests performed on different types of specimens including urine, vaginal swabs, and pharyngeal swabs. Each specimen will be tested using a reference standard of Sanger sequencing and one of the investigational reflex tests to compare results. The target enrollment includes over 300 urine specimens, nearly 500 vaginal swabs, and close to 470 pharyngeal swabs for each reflex test being evaluated. Participants contribute by providing clinical specimens that have tested positive for Neisseria gonorrhoeae through routine care. These specimens undergo both investigational reflex testing and reference genetic sequencing. Researchers will measure how often the investigational tests correctly detect the gyrA 91F mutation compared to sequencing results. Invalid test results will also be recorded. The study runs from April 2025 to July 2026, with outcomes assessed within one day of specimen testing.

Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae