Use of Abbott RealTime CT/NG to Detect Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] in Men Who Have Sex With Men [MSM]
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|ClinicalTrials.gov Identifier: NCT01291264|
Recruitment Status : Terminated (Abbott Molecular stopped funding of study)
First Posted : February 8, 2011
Results First Posted : March 4, 2014
Last Update Posted : March 4, 2014
|Condition or disease|
|Chlamydia Infection Gonococcal Infection Sexually Transmitted Diseases|
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.
|Study Type :||Observational|
|Actual Enrollment :||260 participants|
|Official Title:||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]|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
- Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed. [ Time Frame: 1 day - (At clinic visit) ]This is a single-point prevalence assessment done when subjects present at the STD clinic for routine STD screening. Subjects are not followed beyond the clinic visit.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291264
|United States, California|
|SF City Clinic|
|San Francisco, California, United States, 94103|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Julius Schachter, PhD||University of California, San Francisco|