Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel
- Conditions
- Systemic Infection
- Interventions
- Other: Observational Study
- Registration Number
- NCT03064100
- Lead Sponsor
- BioFire Diagnostics, LLC
- Brief Summary
The purpose of this study is to collect data to support decisions made by BioFire regarding assay development, panel composition, and intended use for the final FilmArray CSI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 18 years of age that present with acute fever.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1500
Inclusion Criteria
- Subject has presented to the ED and is suspected of a systemic infection as indicated by a clinician order for blood culture
- Parent/guardian gives written permission (and assent is obtained from children of sufficient maturity)
- Blood specimen can be collected at the same time as the blood culture during the ED visit (or within 12 hours of being admitted from the ED)
- Specimen is at least 500 µL (1.5 mL collection desired)
Exclusion Criteria
- Parent/guardian is unavailable or unable to give permission, or assent is not obtained (from children of sufficient maturity)
- Physician determines that participation in the study is an unacceptable health risk
- Minimum volume requirement is not met
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Specimens that meet inclusion criteria Observational Study -
- Primary Outcome Measures
Name Time Method Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising FilmArray CSI Panel with respect to reference methods (bacterial culture and independent molecular assays) 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States