Use of Abbott RealTime CT/NG to Detect Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] in Men Who Have Sex With Men [MSM]
Stopped early
Conditions studied: Chlamydia Infection, Gonococcal Infection, Sexually Transmitted Diseases
In brief
Julius Schachter, PhD, (Department of Laboratory Medicine, University of California, San Francisco) and Susan S. Philip, MD MPH (Department of Medicine, University of California, San Francisco) are conducting a study to evaluate the Abbott RealTime CT/NG polymerase chain reaction \[PCR\] assay (which is a nucleic acid amplification test \[NAAT\]) for detecting two sexually transmitted bacteria, Chlamydia trachomatis \[CT\] and Neisseria gonorrhoeae \[NG\], using urine samples and swabs from the throat and rectum of men who have sex with men \[MSM\]. Using this test on these swabs is experimental because it has not been approved by the Food \& Drug Administration.
Key facts
- Study ID
- NCT01291264
- Run by
- University of California, San Francisco
- People needed
- 260
- Starts
- 2012-06-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2014-03-04
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- A subject must be MSM. Subjects must provide verbal consent, must be able to submit all required specimens and must not have urinated within 1 hr prior to providing a study urine specimen.
You may not qualify if…
- Subjects are excluded if they do not have sex with men, refuse to give verbal consent or refuse to allow such consent to be documented in their chart, are unable to provide all required specimens and minimum specimen volume, have been on antibiotic therapy within the last 21 days, have urinated within 1 hr prior to submitting study specimens, and have already been evaluated as part of this trial. Subjects will be excluded if specimens are mishandled or inappropriately stored.
Where it is running
- SF City Clinic — San Francisco, California, United States
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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