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Sponsors and Collaborators: |
University of Pittsburgh National Institutes of Health (NIH) Department of Health and Human Services |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00827697 |
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.
Condition | Intervention |
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Gonorrhea Chlamydia |
Other: Gen-Probe APTIMA Combo2 (AC2) |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Active Control, Single Group Assignment |
Official Title: | A Validation Study of the Gen-Probe APTIMA Combo2 (AC2) for Detecting Chlamydia Trachomatis and Neisseria Gonorrhoeae in Rectal Samples. |
Estimated Enrollment: | 300 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ingrid S Macio, PA-C | 412-641-5455 | imacio@mail.magee.edu |
Contact: Jamie A Haggerty | 412-641-5378 | jhaggerty@mail.magee.edu |
United States, Pennsylvania | |
Magee-Womens Hospital of UPMC | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Ingrid Macio, PA-C 412-641-5455 imacio@mail.magee.edu | |
Contact: Jamie Haggerty 412-641-5378 jhaggerty@mail.magee.edu | |
Sub-Investigator: Harold C Wiesenfeld, MD | |
Sub-Investigator: Richard Beigi, MD | |
Sub-Investigator: Katherine Bunge, MD | |
Sub-Investigator: Susan LaReau, MD | |
Sub-Investigator: Ingrid S Macio, PA-C | |
Sub-Investigator: Abi Jett, CRNP | |
Sub-Investigator: Andrea Trettel, CRNP | |
Pittsburgh AIDS Center for Treatment (PACT) | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Ingrid S Macio, PA-C 412-641-5455 imacio@mail.magee.edu | |
Contact: Jamie A Haggerty 412-641-5378 jhaggerty@mail.magee.edu | |
Sub-Investigator: Ross Cranston, MD | |
Sub-Investigator: Sharon Riddler, MD | |
Sub-Investigator: Deborah McMahon, MD | |
Sub-Investigator: Emanuel Vergis, MD | |
Sub-Investigator: Dawn Renee Weinman, BS | |
Sub-Investigator: Darlene Hoffmann, RN |
Principal Investigator: | Sharon L Hillier, PhD | University of Pittsburgh |
Responsible Party: | Magee-Womens Hospital of UPMC ( Sharon L. Hillier, PhD ) |
Study ID Numbers: | PRO08120504 |
Study First Received: | January 21, 2009 |
Last Updated: | May 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00827697 History of Changes |
Health Authority: | United States: Institutional Review Board |
Gonorrhea Chlamydia Rectal |
Genital Diseases, Female Bacterial Infections Sexually Transmitted Diseases Chlamydia Infections |
Gonorrhea Genital Diseases, Male Neisseriaceae Infections Gram-Negative Bacterial Infections |
Genital Diseases, Female Bacterial Infections Sexually Transmitted Diseases, Bacterial Chlamydiaceae Infections Sexually Transmitted Diseases Chlamydia Infections |
Gonorrhea Genital Diseases, Male Infection Neisseriaceae Infections Gram-Negative Bacterial Infections |