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A Validation Study for Detecting Chlamydia and Gonorrhea in Rectal Samples

NCT00827697 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 399

Last updated 2016-08-17

No results posted yet for this study

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.

Conditions

  • Gonorrhea
  • Chlamydia

Interventions

OTHER

Gen-Probe APTIMA Combo2 (AC2)

Laboratory Test

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Sharon L Hillier, PhD · University of Pittsburgh

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00827697 on ClinicalTrials.gov