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| Tracking Information | |||||||||
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| First Received Date † | January 21, 2009 | ||||||||
| Last Updated Date | January 21, 2009 | ||||||||
| Start Date † | February 2009 | ||||||||
| Current Primary Outcome Measures † |
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| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | A Validation Study for Detecting Chlamydia and Gonorrhea in Rectal Samples | ||||||||
| Official Title † | A Validation Study of the Gen-Probe APTIMA Combo2 (AC2) for Detecting Chlamydia Trachomatis and Neisseria Gonorrhoeae in Rectal Samples. | ||||||||
| Brief Summary | 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. |
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| Detailed Description | This research is being done to compare the results of tests for diagnosing sexually transmitted infections (STIs) from rectal samples. Specifically, this study will test for gonorrhea and Chlamydia from rectal samples and compare the results between standard culture and newer technology (nucleic acid amplification testing otherwise know as "NAAT") used to detect these infections. Gonorrhea and Chlamyia are STIs (infections you get from having sex with someone who is infected). Infections in the rectum may cause symptoms such as rectal discharge, itching and/or pain or may be asymptomatic (no symptoms present). Since these infections are sexually transmitted, it is important to have accurate tests to diagnose and treat these infections to prevent them from being passed onto a sexual partner. NAAT has not been Food and Drug Administration (FDA) approved for use in diagnosing these infections in the rectum. The tests are approved to detect these infections from other sites (cervix and urine) and investigators believe that these tests will be very accurate in detecting these infections in the rectum as well. This study will validate the use of NAAT in rectal samples so that this technology can be used in our research laboratory for future studies that involve testing for STIs from the rectum. There are times when people have signs of inflammation in the rectum (known as proctitis) and an infection or cause is not able to be identified. Investigators believe that this new technology (NAAT) may be able to find reasons (different bacteria) for infection that were not able to be identified with older testing methods. By participating in this study, one of the rectal swabs will also be tested for additional bacteria (called Mycoplasma and Trichomonas). Both of these organisms are sexually transmitted and may be important organisms in the cause of proctitis. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Diagnostic, Open Label, Active Control, Single Group Assignment | ||||||||
| Condition † |
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| Intervention † | Other: Gen-Probe APTIMA Combo2 (AC2) | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Not yet recruiting | ||||||||
| Estimated Enrollment † | 300 | ||||||||
| Estimated Completion Date | February 2010 | ||||||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00827697 | ||||||||
| Responsible Party | Sharon L. Hillier, PhD, Magee-Womens Hospital of UPMC | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | University of Pittsburgh | ||||||||
| Collaborators †† |
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| Investigators † |
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| Information Provided By | University of Pittsburgh | ||||||||
| Verification Date | January 2009 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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