Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM
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.
Sexually Transmitted Diseases
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM|
- Positive nucleic acid amplification result for Chlamydia trachomatis or Neisseria gonorrhoeae. [ Time Frame: At enrollment/screening ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
self-collected glans swab; clinician-collected rectal and pharyngeal swabs
|Study Start Date:||October 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|