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

December 19, 2016 updated by: BioFire Diagnostics, LLC
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1514

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medecine
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospitals & Clinics
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Primary Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients under the age of 3 with acute fever.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Epidemiology of pathogens in pediatric patients with acute fever
Time Frame: 15 Months
15 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioFire Diagnostics, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 18, 2015

First Submitted That Met QC Criteria

June 18, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Estimate)

December 21, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFDxFIPilot

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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