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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02477683

Enrollment

1514

Registered

2015-06-23

Start date

2015-10-31

Completion date

2016-10-31

Last updated

2016-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Fever

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Utility of multiplexed testing for pathogens in pediatric patients with acute fever	15 months

Secondary

Measure	Time frame
Epidemiology of pathogens in pediatric patients with acute fever	15 Months

Countries

United States

Outcome results