Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187902
Status:
COMPLETED
Last Update Posted:
2011-04-14
First Post:
2005-09-15
Brief Title:
Evaluation of NAATs for Detection of C Trachomatis and N Gonorrhoeae From Pharynx Rectum Glans Urethra of MSM
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Evaluation of NAATs for Detection of C Trachomatis and N Gonorrhoeae From Pharynx Rectum Glans Urethra of MSM
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
For all subjects enrolled in the study the following clinical data information will be obtained 1 reason for exam 2 subjects 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 CTNG NAAT TMA at DPH 2 NG culture at DPH and 3 NAATs for CTNG TMA SDA and CT culture at UCSF Four rectal swabs will be tested for 1 CTNG NAAT TMA at DPH 2 NG culture at DPH and 3 NAATs for CTNG 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 CTNG 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
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 CTNG NAAT TMA at DPH 2 NG culture at DPH and 3 NAATs for CTNG TMA SDA and CT culture at UCSF Four rectal swabs will be tested for 1 CTNG NAAT TMA at DPH 2 NG culture at DPH and 3 NAATs for CTNG 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 CTNG 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None