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NCT02099760 · ClinicalTrials.gov registry record
Cepheid Rectal Sample Validation Study
A clinical trial, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 402
- Enrollment target
NCT02099760: Completed study, sponsored by University of Pittsburgh.
NCT02099760 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 402 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02099760 has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 402 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Compare the sensitivity and specificity of the Xpert NG to the AC2 and culture in detecting GC in rectal samples Compare the sensitivity and specificity of the Xpert CT to AC2 (and as necessary, for discrepant results, to Aptima CT assay) in detecting CT in rectal samples
Interventions
- DEVICE STD testing (GC/Ct/trich)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-04 |
What the finished NCT02099760 record still lists
NCT02099760 is an observational study that tracks outcomes without assigning an intervention. The registered 402 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which STD testing (GC/Ct/trich) is the first listed.
NCT02099760 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02099760 about?
NCT02099760 is a clinical study titled "Cepheid Rectal Sample Validation Study". 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 an...
What is the current status of trial NCT02099760?
This trial is currently completed. The enrollment target is 402 participants. The study started on 2013-12. Estimated completion is 2015-04.
What interventions are being tested in trial NCT02099760?
The interventions under investigation include: STD testing (GC/Ct/trich) (DEVICE).
Who is sponsoring clinical trial NCT02099760?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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