A Validation Study for Detecting Chlamydia and Gonorrhea in Rectal Samples

Completed

Conditions studied: Gonorrhea, Chlamydia

In brief

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.

Key facts

Study ID

NCT00827697

Run by

University of Pittsburgh

People needed

399

Starts

2009-05-01

Expected to finish

2010-03-01

Last updated by the study team

2016-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female subjects aged 18 and older
• Women or men who have a history of engaging in receptive anal intercourse
• Willing to provide written informed consent for participation in this study

You may not qualify if…

• Use of oral antibiotics in the past 7 days
• Use of rectal douche or other rectal product in the past 24 hours

Where it is running

• Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• Pittsburgh AIDS Center for Treatment (PACT) — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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