Clinical Trial: A Multi-Site Clinical Evaluation of the ARIES Bordetella Assay in Symptomatic Patients
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: A Multi-Site Clinical Evaluation of the ARIES Bordetella Assay in Symptomatic Patients
Brief Summary: A three-arm, multi-site clinical evaluation of the ARIES Bordetella Assay for the detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acids in prospectively collected, de-identified, left-over clinical specimens; banked, pre-selected clinical specimens; and contrived specimens.
Detailed Summary:
Sponsor: Luminex Molecular Diagnostics
Current Primary Outcome: Specificity and sensitivity of the ARIES Bordetella Assay in patients suspected of having respiratory infection attributable to B. pertussis or B. parapertussis. [ Time Frame: 5 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical performance of the ARIES Bordetella Assay per clinical site. [ Time Frame: 5 months ]
- Clinical performance of the ARIES Bordetella Assay per age group. [ Time Frame: 5 months ]
- Clinical performance of the ARIES Bordetella Assay per patient sub-population. [ Time Frame: 5 months ]
Original Secondary Outcome: Same as current
Information By: Luminex Molecular Diagnostics
Dates:
Date Received: July 12, 2016
Date Started: July 2016
Date Completion: April 2017
Last Updated: January 30, 2017
Last Verified: January 2017
