Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel

Status unconfirmed

Conditions studied: Systemic Infection

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 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.

Key facts

Study ID

NCT03064100

Run by

BioFire Diagnostics, LLC

People needed

1500

Starts

2017-03-21

Expected to finish

2018-02-01

Last updated by the study team

2017-07-21

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Emory University — Atlanta, Georgia, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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