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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00187902 |
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Date of registration:
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15/09/2005 |
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Primary sponsor: |
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Public title:
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Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM
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Scientific title:
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Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM |
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Date of first enrolment:
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October 2005 |
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Target sample size:
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907 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00187902 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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Countries of recruitment
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United States
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Contacts
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Name:
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Jeffrey D Klausner, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Public Health, San Francisco, CA USA |
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Name:
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Julius Schachter, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A subject must be a man who has sex with men (MSM). Subjects must provide verbal
consent, must be able to submit all required specimens and must not have urinated
within 1 hr prior to providing a study urine specimen.
Exclusion Criteria:
- Subjects are excluded if they do not have sex with men, refuse to give verbal
consent, are unable to provide all required specimens and minimum specimen volume,
have been on antibiotic therapy within the last 21 days, have urinated within 1 hr
prior to submitting study specimens, and have already been evaluated as part of this
trial. Subjects will be excluded if specimens are mishandled or inappropriately
stored.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Chlamydia
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Gonorrhea
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Sexually Transmitted Diseases
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Primary Outcome(s)
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Positive nucleic acid amplification result for Chlamydia trachomatis or Neisseria gonorrhoeae.
[Time Frame: At enrollment/screening]
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Secondary ID(s)
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H1079-26791-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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