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A Validation Study for Detecting Chlamydia and Gonorrhea in Rectal Samples
This study is not yet open for participant recruitment.
Verified by University of Pittsburgh, January 2009
First Received: January 21, 2009   No Changes Posted
Sponsors and Collaborators: University of Pittsburgh
National Institutes of Health (NIH)
Department of Health and Human Services
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00827697
  Purpose

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
Gonorrhea
Chlamydia
Other: Gen-Probe APTIMA Combo2 (AC2)

MedlinePlus related topics: Chlamydia Infections Gonorrhea
U.S. FDA Resources
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.

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 ]

Estimated Enrollment: 300
Study Start Date: February 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 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.

  Eligibility

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

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

Contacts
Contact: Ingrid S Macio, PA-C 412-641-5455 imacio@mail.magee.edu
Contact: Jamie A Haggerty 412-641-5378 jhaggerty@mail.magee.edu

Locations
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
Investigators
Principal Investigator: Sharon L Hillier, PhD University of Pittsburgh
  More Information

No publications provided

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

Keywords provided by University of Pittsburgh:
Gonorrhea
Chlamydia
Rectal

Study placed in the following topic categories:
Genital Diseases, Female
Bacterial Infections
Sexually Transmitted Diseases
Chlamydia Infections
Gonorrhea
Genital Diseases, Male
Neisseriaceae Infections
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 06, 2009