Pilot Evaluation of the FilmArray® Febrile Infant (FI) Panel

Completed

Conditions studied: Acute Fever

In brief

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.

Key facts

Study ID

NCT02477683

Run by

BioFire Diagnostics, LLC

People needed

1514

Starts

2015-10-01

Expected to finish

2016-10-01

Last updated by the study team

2016-12-21

Who can join

Age: any, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• under age of 3
• has fever with no obvious focal infection
• written informed parental permission

You may not qualify if…

• parent/legal guardian unable to provide permission
• participation determined by a physician to be detrimental to patient health

Where it is running

• Emory University — Atlanta, Georgia, United States
• Indiana University School of Medecine — Indianapolis, Indiana, United States
• Children's Mercy Hospitals & Clinics — Kansas City, Missouri, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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