Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00187902|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 14, 2011
|Condition or disease|
|Sexually Transmitted Diseases Chlamydia Gonorrhea|
For all subjects 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, three clinician-collected pharyngeal, four rectal swabs (three clinician-collected, 1 self-collected) specimens, one glans swab (self-collected) and a first catch urine specimen (approximately 25 ml) will be obtained. The collection order of the clinician collected swabs will be randomized.
Three pharyngeal swabs will be tested for: 1) CT/NG NAAT (TMA) at DPH, 2) NG culture at DPH and 3) NAATs for CT/NG (TMA, SDA) and CT culture at UCSF. Four rectal swabs will be tested for: 1) CT/NG NAAT (TMA) at DPH, 2) NG culture at DPH and 3) NAATs for CT/NG on Clinician- and self-collected rectal swab (TMA, SDA) and CT culture at UCSF. Self-collected glans swab and the FCU will be tested by NAATs for CT/NG (TMA, SDA) at UCSF. All NAAT specimens collected in a universal NAAT transport medium. After specimen processing, samples will be frozen at -70 C for discrepant analysis.
|Study Type :||Observational|
|Actual Enrollment :||907 participants|
|Official Title:||Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||December 2008|
- Positive nucleic acid amplification result for Chlamydia trachomatis or Neisseria gonorrhoeae. [ Time Frame: At enrollment/screening ]
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): NCT00187902
|United States, California|
|San Francisco, California, United States, 94103|
|Principal Investigator:||Julius Schachter, PhD||University of California, San Francisco|
|Principal Investigator:||Jeffrey D Klausner, MD, MPH||Department of Public Health, San Francisco, CA USA|