Cepheid Rectal Sample Validation Study
Completed
Conditions studied: Gonorrhea, Chlamydia, Trichomonas
In brief
The purpose of this study is to validate Xpert CT/NG for the detection of CT and GC in rectal samples as part of the PA DOH and CLIA requirements. The evaluation of samples obtained from the pharynx is exploratory and will provide new information on the frequency of pharyngeal infection due to CT and GC. A secondary objective will be to evaluate the prevalence of Trichomonas vaginalis in vaginal and rectal samples using both the Xpert system and AC2 to assess whether women positive for this pathogen rectally usually or always have vaginal infection due to this pathogen. The investigators hypothesis is that real-time PCR (polymerase chain reaction) amplification testing with the Cepheid Xpert CT/NG will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal samples. The investigators also hypothesize that Xpert CT/NG will be equivalent to the Gen-Probe APTIMA Combo2 (AC2) in detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal samples.
Key facts
- Study ID
- NCT02099760
- Run by
- University of Pittsburgh
- People needed
- 402
- Starts
- 2013-12-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2019-02-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male and female participants 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
- If female, use of a vaginal douche or vaginal product in the past 24 hours
Where it is running
- Allegheny County Health Department Sexually Transmitted Diseases Clinic — Pittsburgh, Pennsylvania, United States
- Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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