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A Validation Study for Detecting Chlamydia and Gonorrhea in Rectal Samples

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00827697
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : August 17, 2016
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Sharon Hillier, University of Pittsburgh

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.

Condition or disease Intervention/treatment
Gonorrhea Chlamydia Other: Gen-Probe APTIMA Combo2 (AC2)

Detailed 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.

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Study Type : Observational
Actual Enrollment : 399 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Validation Study of the Gen-Probe APTIMA Combo2 (AC2) for Detecting Chlamydia Trachomatis and Neisseria Gonorrhoeae in Rectal Samples.
Study Start Date : May 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Gen-Probe APTIMA Combo2 (AC2)
    Laboratory Test

Primary Outcome Measures :
  1. Sensitivity and specificity of AC2 in detecting Neisseria gonorrhoeae in rectal samples [ Time Frame: Visit 1 ]
    Sensitivity and specificity of AC2 to ProbeTec and culture in detecting Neisseria gonorrhoeae in rectal samples

  2. Sensitivity and specificity of AC2 in detecting Chlamydia trachomatis in rectal samples [ Time Frame: Visit 1 ]
    Compare the sensitivity and specificity of the AC2 to ProbeTec and as necessary, for discrepant results, to APTIMA CT assay in detecting Chlamydia trachomatis in rectal sample

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women (n=175) and men who have sex with men (n=224) with a lifetime history of anal intercourse by self-report

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00827697

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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)
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Sharon L Hillier, PhD University of Pittsburgh
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Responsible Party: Sharon Hillier, Richard Sweet Professor of Reproductive Infectious Disease, University of Pittsburgh Identifier: NCT00827697    
Other Study ID Numbers: PRO08120504
UM1AI068633 ( U.S. NIH Grant/Contract )
5UM1AI106707 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sharon Hillier, University of Pittsburgh:
Additional relevant MeSH terms:
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Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Neisseriaceae Infections