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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Infectious Gastroenteritis

Intervention / Treatment
-----------------
* Device: FilmArray™ Gastrointestinal (GI) Panel


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Device: FilmArray™ Gastrointestinal (GI) Panel<br>* 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<br>|
| No Intervention: Pre-intervention<br>Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel | Describing of etiology of diarrheal illness in the study as identified by each method | Seven to ten days after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCR, rapid diagnostics, multiplex, polymerase chain reaction, BioFire Diagnostics, Infectious gastroenteritis, Diarrheal disease, Emergency department, FilmArray, FilmArray GI Panel