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

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.

Study Overview

• Status: Unknown
• Conditions: Systemic Infection
• Intervention / Treatment: Other: Observational Study

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital of Los Angeles
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric patients under the age of 18 suspected of systemic infection

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Specimens that meet inclusion criteria	Other: Observational Study; Exclusion from the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: BioFire Diagnostics, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2017
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Infections; Communicable Diseases
• Other Study ID Numbers: BFDxCSIPilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No