Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel
1 other identifier
observational
1,500
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2017
CompletedFirst Posted
Study publicly available on registry
February 24, 2017
CompletedStudy Start
First participant enrolled
March 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedJuly 21, 2017
February 1, 2017
11 months
February 14, 2017
July 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Specimens that meet inclusion criteria
Interventions
Eligibility Criteria
Pediatric patients under the age of 18 suspected of systemic infection
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Emory University
Atlanta, Georgia, 30329, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Biospecimen
Plasma and Whole Blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2017
First Posted
February 24, 2017
Study Start
March 21, 2017
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
July 21, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share