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Trial record 2 of 81 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment dates were 06/06/12 to 09/19/12. Study was done at the San Francisco City STD Clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Men Who Have Sex With Men 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.

Participant Flow:   Overall Study
    Men Who Have Sex With Men
STARTED   260 
COMPLETED   260 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Men who have sex with men

Reporting Groups
  Description
Men Who Have Sex With Men 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.

Baseline Measures
   Men Who Have Sex With Men 
Overall Participants Analyzed 
[Units: Participants]
 260 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   260 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   0 
Male   260 


  Outcome Measures

1.  Primary:   Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.   [ Time Frame: 1 day - (At clinic visit) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our limitations are small number of subjects enrolled due to early termination of the study and we had no pharyngeal CT infections.


  More Information

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
e-mail: julius.schachter@ucsf.edu


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