Pilot Evaluation of the FilmArray® Febrile Infant (FI) Panel | NCT02477683

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

NCT02477683

Sponsor

BioFire Diagnostics, LLC

Status

Completed

Last Update Posted

Dec 21, 2016Estimated

Enrollment

1,514Actual

Phase

Not provided

Conditions

Acute Fever

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Jun 18, 2015

First Submission Date that Met QC Criteria

Jun 18, 2015

First Posted Date

Jun 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2016

Last Update Posted Date

Dec 21, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,514Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Years

Standard Ages

Child

Study Population

Pediatric patients under the age of 3 with acute fever.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University		Atlanta	Georgia	30329	United States
Indiana University School of Medecine