Gonorrhea Clinical Trial
Official title:
A Validation Study of the Gen-Probe APTIMA Combo2 (AC2) for Detecting Chlamydia Trachomatis and Neisseria Gonorrhoeae in Rectal Samples.
Verified date | August 2016 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
Our hypothesis is that nucleic acid amplification testing (NAAT) with the APTIMA Combo2 (AC2) will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal samples. We also hypothesize that AC2 will be equivalent to NAAT with the Becton Dickinson ProbeTec in detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal samples.
Status | Completed |
Enrollment | 399 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Male and female subjects aged 18 and older 2. Women or men who have a history of engaging in receptive anal intercourse 3. Willing to provide written informed consent for participation in this study Exclusion Criteria: 1. Use of oral antibiotics in the past 7 days 2. Use of rectal douche or other rectal product in the past 24 hours |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania |
United States | Pittsburgh AIDS Center for Treatment (PACT) | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and specificity of AC2 in detecting Neisseria gonorrhoeae in rectal samples | Sensitivity and specificity of AC2 to ProbeTec and culture in detecting Neisseria gonorrhoeae in rectal samples | Visit 1 | No |
Primary | Sensitivity and specificity of AC2 in detecting Chlamydia trachomatis in rectal samples | Compare the sensitivity and specificity of the AC2 to ProbeTec and as necessary, for discrepant results, to APTIMA CT assay in detecting Chlamydia trachomatis in rectal sample | Visit 1 | No |
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