A Validation Study for Detecting Chlamydia and Gonorrhea in Rectal Samples

This study has been completed.
National Institutes of Health (NIH)
Department of Health and Human Services
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
First received: January 21, 2009
Last updated: March 2, 2010
Last verified: March 2010
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
Other: Gen-Probe APTIMA Combo2 (AC2)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Validation Study of the Gen-Probe APTIMA Combo2 (AC2) for Detecting Chlamydia Trachomatis and Neisseria Gonorrhoeae in Rectal Samples.

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Compare the sensitivity and specificity of the AC2 to ProbeTec and culture in detecting GC in rectal samples [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
  • Compare the sensitivity and specificity of the AC2 to ProbeTec and as necessary, for discrepant results, to APTIMA CT assay in detecting CT in rectal samples [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: May 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Gen-Probe APTIMA Combo2 (AC2)
    Laboratory Test
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827697

United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Pittsburgh AIDS Center for Treatment (PACT)
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
Department of Health and Human Services
Principal Investigator: Sharon L Hillier, PhD University of Pittsburgh
  More Information

Responsible Party: Sharon L. Hillier, PhD, Magee-Womens Hospital of UPMC
ClinicalTrials.gov Identifier: NCT00827697     History of Changes
Other Study ID Numbers: PRO08120504 
Study First Received: January 21, 2009
Last Updated: March 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Additional relevant MeSH terms:
Chlamydia Infections
Bacterial Infections
Chlamydiaceae Infections
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial

ClinicalTrials.gov processed this record on May 26, 2016