Pilot Evaluation of the FilmArray® Febrile Infant (FI) 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 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.

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Key information

Conditions

Acute Fever

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University, Atlanta, Georgia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

under age of 3
has fever with no obvious focal infection
written informed parental permission

Exclusion criteria

parent/legal guardian unable to provide permission
participation determined by a physician to be detrimental to patient health

Treatment and study plan

Primary outcomes

Utility of multiplexed testing for pathogens in pediatric patients with acute fever

Time frame: 15 months

Secondary outcomes

Epidemiology of pathogens in pediatric patients with acute fever

Time frame: 15 Months

Sponsors and collaborators

Lead sponsor

BioFire Diagnostics, LLC

Industry

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jun 23, 2015
Registry last updated: Dec 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.