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

NCT ID: NCT02477683

Last Updated: 2016-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1514 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Fever

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioFire Diagnostics, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Indiana University School of Medecine

Indianapolis, Indiana, United States

Site Status

Children's Mercy Hospitals & Clinics

Kansas City, Missouri, United States

Site Status

Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Primary Children's Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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BFDxFIPilot

Identifier Type: -

Identifier Source: org_study_id