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Trial record 2 of 85 for:    chlamydia trachomatis | "Sexually Transmitted Diseases"

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
Sponsor:
Collaborator:
Abbott Molecular
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Conditions Chlamydia Infection
Gonococcal Infection
Sexually Transmitted Diseases
Enrollment 260
Recruitment Details Recruitment dates were 06/06/12 to 09/19/12. Study was done at the San Francisco City STD Clinic.
Pre-assignment Details  
Arm/Group Title Men Who Have Sex With Men
Hide Arm/Group Description The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
Period Title: Overall Study
Started 260
Completed 260
Not Completed 0
Arm/Group Title Men Who Have Sex With Men
Hide Arm/Group Description The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
Overall Number of Baseline Participants 260
Hide Baseline Analysis Population Description
Men who have sex with men
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants
<=18 years
0
   0.0%
Between 18 and 65 years
260
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants
Female
0
   0.0%
Male
260
 100.0%
1.Primary Outcome
Title Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.
Hide Description 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.
Time Frame 1 day - (At clinic visit)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Men Who Have Sex With Men
Hide Arm/Group Description:
The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
Overall Number of Participants Analyzed 260
Measure Type: Number
Unit of Measure: Positive test result
Oropharynx tested by RealTime for NG 11
Oropharynx tested by AC2 for NG 12
Rectum tested by RealTime for NG 16
Rectum tested by AC2 for NG 20
FCU tested by RealTime for NG 11
FCU tested by AC2 for NG 12
Oropharynx tested by RealTime for CT 0
Oropharynx tested by AC2 for CT 0
Rectum tested by RealTime for CT 17
Rectum tested by AC2 for CT 17
FCU tested by RealTime for CT 9
FCU tested by AC2 for CT 8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Men Who Have Sex With Men
Hide Arm/Group Description The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
All-Cause Mortality
Men Who Have Sex With Men
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Men Who Have Sex With Men
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Men Who Have Sex With Men
Affected / at Risk (%)
Total   0/0 
Our limitations are small number of subjects enrolled due to early termination of the study and we had no pharyngeal CT infections.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Julius Schachter, Professor of Laboratory Medicine
Organization: University of California, San Francisco
Phone: 415 824 5115
Publications:
Laboratory Diagnostic Testing for Chlamydia trachomatis and Neisseria gonorrhoeae. American Public Health Laboratories/Center for Disease Control & Prevention Panel Summary Reports. January 2009. Internet. Accessed 8 November 2010. http://www.aphl.org/aphlprograms/infectious/std/Documents/CTGCLabGuidelinesMeetingReport.pdf
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01291264     History of Changes
Other Study ID Numbers: 10-04134
First Submitted: February 1, 2011
First Posted: February 8, 2011
Results First Submitted: January 21, 2014
Results First Posted: March 4, 2014
Last Update Posted: March 4, 2014