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

Systemic Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03064100
• Other study ID #: BFDxCSIPilot
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 14, 2017
• Last updated: July 18, 2017
• Start date: March 21, 2017
• Est. completion date: February 2018

Study information

• Verified date: February 2017
• Source: BioFire Diagnostics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1500
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Sepsis
• Systemic Infection

Intervention

Other:
• Observational Study
Exclusion from the study

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Children's Hospital of Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
BioFire Diagnostics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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