Pilot Evaluation of the FilmArray® Febrile Infant (FI) Panel
Completed
- Conditions
- Acute Fever
- Registration Number
- NCT02477683
- 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 FI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 3 years of age that present with acute fever.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1514
Inclusion Criteria
- under age of 3
- has fever with no obvious focal infection
- written informed parental permission
Exclusion Criteria
- parent/legal guardian unable to provide permission
- participation determined by a physician to be detrimental to patient health
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Utility of multiplexed testing for pathogens in pediatric patients with acute fever 15 months
- Secondary Outcome Measures
Name Time Method Epidemiology of pathogens in pediatric patients with acute fever 15 Months
Trial Locations
- Locations (6)
Emory University
🇺🇸Atlanta, Georgia, United States
Indiana University School of Medecine
🇺🇸Indianapolis, Indiana, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Children's Mercy Hospitals & Clinics
🇺🇸Kansas City, Missouri, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States