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

BioFire Diagnostics

Status: Completed

Conditions: Infectious Gastroenteritis

Treatments: Device: FilmArray™ Gastrointestinal (GI) Panel

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02248285

DX-SDY-019839

R01AI104593 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,545 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children (<18 years) presenting to the ED or onsite urgent care center with symptoms of gastroenteritis (e.g. diarrhea, vomiting, nausea, etc.)
• Duration of symptoms at least 24 hours but < 14 days
• Able to provide stool specimen at time of enrollment or within the next two calendar days
• Parent or guardian able to provide permission and subject able to provide assent, if appropriate

Exclusion criteria

• Undefined onset of illness or symptoms for ≥14 days
• Unable to complete questionnaire or give informed consent because of language barrier
• Those unable to provide stool specimen at time of enrollment or within two calendar days
• Previous enrollment in this study

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,545 participants in 2 patient groups

Intervention

Experimental group

Description:

FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.

Treatment:

Device: FilmArray™ Gastrointestinal (GI) Panel

Pre-intervention

No Intervention group

Description:

Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.