Pilot Evaluation of the FilmArray® Febrile Infant (FI) Panel
1 other identifier
observational
1,514
1 country
6
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 FI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 3 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 Oct 2015
Shorter than P25 for all trials
6 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
June 18, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedDecember 21, 2016
December 1, 2016
1 year
June 18, 2015
December 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Utility of multiplexed testing for pathogens in pediatric patients with acute fever
15 months
Secondary Outcomes (1)
Epidemiology of pathogens in pediatric patients with acute fever
15 Months
Eligibility Criteria
Pediatric patients under the age of 3 with acute fever.
You may qualify if:
- under age of 3
- has fever with no obvious focal infection
- written informed parental permission
You may not qualify if:
- parent/legal guardian unable to provide permission
- participation determined by a physician to be detrimental to patient health
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Emory University
Atlanta, Georgia, 30329, United States
Indiana University School of Medecine
Indianapolis, Indiana, 46202, United States
Children's Mercy Hospitals & Clinics
Kansas City, Missouri, 64108, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Primary Children's Hospital
Salt Lake City, Utah, 84108, United States
Biospecimen
Plasma and Whole Blood
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2015
First Posted
June 23, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
December 21, 2016
Record last verified: 2016-12