Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM

Completed

Conditions studied: Sexually Transmitted Diseases, Chlamydia, Gonorrhea

In brief

Julius Schachter, PhD, from the Department of Laboratory Medicine at UCSF, and Jeffrey Klausner, MD, from the Department of Public Health, are conducting a study to evaluate a type of test (nucleic acid amplification test) for the detection of two sexually transmitted diseases, Chlamydia trachomatis and Neisseria gonorrhoeae, in men who have sex with men (MSM), using urine samples and swabs taken from the throat (pharynx), tip of penis (glans), and rectum. The use of nucleic acid amplification tests on these swabs is experimental, which means that the use of the tests for this purpose have not been approved by the Food \& Drug Administration.

Key facts

Study ID

NCT00187902

Run by

University of California, San Francisco

People needed

907

Starts

2005-10-01

Expected to finish

2008-12-01

Last updated by the study team

2011-04-14

Who can join

Age: any. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• A subject must be a man who has sex with men (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, 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

• City Clinic — San Francisco, California, United States

Full record on ClinicalTrials.gov

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