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NCT02968758 · ClinicalTrials.gov registry record · NA
Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
A NA study of Clostridium Difficile Infection, sponsored by Meridian Bioscience.
- Completed
- Registry status
- NA
- Development phase
- 2,461
- Enrollment target
- 7
- Study locations
NCT02968758: Completed NA study of Clostridium Difficile Infection, sponsored by Meridian Bioscience.
NCT02968758 is a NA study of Clostridium Difficile Infection that has completed, run by Meridian Bioscience. The registered enrollment target is 2,461 participants, below the 11,877-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (79% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02968758, a NA study of Clostridium Difficile Infection, has completed, sponsored by Meridian Bioscience.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,461 participants
- Enrollment target
- 7
- Study locations
Study Summary
The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a conventional method considered as gold standard for detection of toxigenic Clostridium difficile in stool specimens.
Primary Outcome
To establish the performance characteristics of the GenePOC CDiff System for its use in determining the presence of CDiff in liquid/unformed stool specimen obtained from patients suspected of having C. difficile infection (CDI). Sensitivity will be established as the proportion of positives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method. Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC
Conditions Studied
Interventions
- DEVICE Comparison between GenePOC PCR and Reference Method
Study Locations (7)
Indiana
- Wishard Health Services - Indianapolis
Maryland
- John Hopkins University School of Medicine - Baltimore
Michigan
- Detroit Medical Center University Laboratories - Detroit
New Mexico
- Tricore Laboratory University of New Mexico - Albuquerque
Wisconsin
- Medical College of Wisconsin - Milwaukee
Ontario
- Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex - Toronto
Quebec
- McGill University Health Centre - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,461 participants |
| Start Date | 2017-02-06 |
| Est. Completion | 2017-08-10 |
| Phase | NA |
What the finished NCT02968758 record still lists
NCT02968758 is an interventional study that assigns participants to a tested intervention. Its 2,461 participants enrollment target places it among the larger protocols in the corpus, below the 11,877-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Clostridium Difficile Infection appearing as the primary indexed condition, and to 1 intervention - of which Comparison between GenePOC PCR and Reference Method is the first listed.
NCT02968758 lists 7 locations in 7 states (Indiana, Maryland, Michigan).
Frequently Asked Questions
What is clinical trial NCT02968758 about?
NCT02968758 is a clinical study titled "Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains". The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a conventional method consid...
What is the current status of trial NCT02968758?
This trial is currently completed. It is a NA study. The enrollment target is 2,461 participants. The study started on 2017-02-06. Estimated completion is 2017-08-10.
What conditions does trial NCT02968758 study?
This clinical trial studies the following conditions: Clostridium Difficile Infection.
What interventions are being tested in trial NCT02968758?
The interventions under investigation include: Comparison between GenePOC PCR and Reference Method (DEVICE).
Who is sponsoring clinical trial NCT02968758?
This trial is sponsored by Meridian Bioscience, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02968758 being conducted?
This trial has 7 study locations across Indiana, Maryland, Michigan, New Mexico, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02968758's enrollment target sits among peer trials
2,461 3rd of 13 higher than 11 of 13 other Clostridium Difficile Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clostridium Difficile Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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