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

Completed · Not applicable

Conditions studied: Infectious Gastroenteritis

In brief

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.

Key facts

Study ID

NCT02248285

Run by

BioFire Diagnostics, LLC

People needed

1545

Starts

2015-04-01

Expected to finish

2016-08-01

Last updated by the study team

2017-12-26

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Brown University, Lifespan — Providence, Rhode Island, United States
• University of Utah, Primary Children's Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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