NCT01291264

Use of Abbott RealTime CT/NG to Detect Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] in Men Who Have Sex With Men [MSM]

Evaluation of Abbott RealTime CT/NG for the Detection of Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] From the Pharynx, Rectum & Urethra of Men Who Have Sex With Men [MSM]

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 260 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

For each subject enrolled in the study, the following clinical data information will be obtained: 1) reason for exam, 2) subject's signs and symptoms and 3) clinical assessment. For each subject enrolled in the study, two clinician-collected pharyngeal swabs, two clinician-collected rectal swabs, and a first catch urine specimen (approximately 25 ml) will be obtained. The collection order of the clinician-collected swabs will be randomized. Two pharyngeal swabs will be tested at the research laboratory using: 1) APTIMA COMBO 2® \[AC2\](Gen-Probe Inc, San Diego, CA); and 2) Abbott RealTime CT/NG \[RealTime\](Abbott Molecular, Des Plains, IL). Two rectal swabs will be tested at the research laboratory using: 1) AC2; and 2) RealTime. A first-catch urine \[FCU\] specimen will be split out at San Francisco Department of Public Health laboratory and sent to the Chlamydia Research Laboratory for analysis using: 1)AC2; and 2) RealTime. All NAAT specimens are collected in the manufacturer's recommended NAAT transport medium. After specimen processing, samples will be frozen at -70ºC for discrepant analysis.

Conditions

• Chlamydia Infection
• Gonococcal Infection
• Sexually Transmitted Diseases

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-02-08
• Last updated: 2014-03-04
• Results posted: 2014-03-04

Locations

2 sites across 1 country: United States