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

BioFire Diagnostics

Status: Unknown

Conditions: Systemic Infection

Treatments: Other: Observational Study

Study type: Observational

Funder types: Industry

Identifiers

NCT03064100

BFDxCSIPilot

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,500 participants in 1 patient group

Specimens that meet inclusion criteria

Treatment:

Other: Observational Study