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Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study

NCT02248285 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1545

Last updated 2017-12-26

Study results available
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Summary

BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel, a rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common microorganisms responsible for infectious gastroenteritis (http://filmarray.com/the-panels/) from a stool specimen collected in Cary Blair enteric transport media. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014.

The FilmArray GI Panel offers improvements over conventional laboratory testing which include: reduced turnaround time from specimen to result, reduced laboratory labor costs, increased sensitivity and specificity relative to current clinical reference methods, and larger breadth of organism identification than is available using standard methods. Because of these attributes, the results from this test have the potential to enable clinicians to more accurately diagnose and treat GI illness in a reduced time frame.

Collaborators at the University of Utah, Brown University/Lifespan, and BioFire Diagnostics have designed a study to evaluate health outcomes of pediatric subjects presenting to emergency departments with GI illness before and after establishing the FilmArray GI Panel as the standard of care method for stool pathogen analysis. It is hypothesized that the rapid (\~ 1 hour turnaround time), sensitive, specific, and comprehensive results provided by the FilmArray GI Panel will allow clinicians to more rapidly diagnose GI illness, initiate appropriate therapy and provide guidance when compared to the pre-implementation period.

Conditions

  • Infectious Gastroenteritis

Interventions

DEVICE

FilmArray™ Gastrointestinal (GI) Panel

BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • BioFire Diagnostics, LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02248285 on ClinicalTrials.gov