Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


NCT number NCT00827697
Study type Observational
Source University of Pittsburgh
Contact
Status Completed
Phase N/A
Start date May 2009
Completion date March 2010

See also
  Status Clinical Trial Phase
Completed NCT01439503 - Safer Sex Program for Young African-American Men Phase 2
Completed NCT00381992 - Risk Assessment of Long-Haul Truck Drivers N/A
Completed NCT03294395 - New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea Phase 3
Not yet recruiting NCT06428643 - A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities N/A
Completed NCT03896776 - A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0) N/A
Completed NCT03718806 - Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin Phase 1
Completed NCT04010539 - A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Phase 3
Completed NCT00187902 - Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM N/A
Completed NCT00262106 - Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection Phase 3
Completed NCT00207506 - Lay Health Advisors for Sexually Transmitted Disease Prevention Phase 1/Phase 2
Completed NCT04553068 - Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection Phase 3
Active, not recruiting NCT03959527 - Zoliflodacin in Uncomplicated Gonorrhoea Phase 3
Active, not recruiting NCT03980223 - Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men Phase 4
Completed NCT01465607 - Implementation of an Efficacious Intervention for High Risk Women in Mexico N/A
Terminated NCT00120770 - Cellulose Sulfate (CS) Gel and HIV in Nigeria Phase 3
Completed NCT02391233 - Multimedia WORTH With Black Drug-Involved Women on Probation N/A
Recruiting NCT05766904 - Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections Phase 3
Completed NCT04297436 - Gonococcal Vaccine Study in Key Populations in Kenya N/A
Completed NCT03098329 - Check it: A New Approach to Controlling Chlamydia Transmission in Young People N/A
Completed NCT02122094 - Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities N/A