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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 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 402 participants.
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.
Interventions
- DEVICE STD testing (GC/Ct/trich)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02099760
The ClinicalTrials.gov registry entry for NCT02099760 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 402 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which STD testing (GC/Ct/trich) is the first listed.
NCT02099760 reports 0 study locations.
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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