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.
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.
This research is being done to compare the results of tests for diagnosing sexually
transmitted infections (STI) 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 Chlamydia 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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Observational Model: Cohort, Time Perspective: Cross-Sectional
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