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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02248285
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
BioFire Diagnostics, LLC

Study Description
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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.


Condition or disease Intervention/treatment Phase
Infectious Gastroenteritis Device: FilmArray™ Gastrointestinal (GI) Panel Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1545 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study
Study Start Date : April 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
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
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
No Intervention: Pre-intervention
Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.


Outcome Measures
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Primary Outcome Measures :
  1. Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel [ Time Frame: Seven to ten days after enrollment ]
    Describing of etiology of diarrheal illness in the study as identified by each method


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248285


Locations
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United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Rhode Island
Brown University, Lifespan
Providence, Rhode Island, United States, 02903
United States, Utah
University of Utah, Primary Children's Hospital
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
BioFire Diagnostics, LLC
National Institute of Allergy and Infectious Diseases (NIAID)
More Information
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Publications:
FDA. FDA clearance for FilmArray Gastrointestinal Panel, May 2, 2014. http://www.accessdata.fda.gov/cdrh_docs/reviews/K140407.pdf (2014).

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Responsible Party: BioFire Diagnostics, LLC
ClinicalTrials.gov Identifier: NCT02248285    
Other Study ID Numbers: DX-SDY-019839
R01AI104593 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2014    Key Record Dates
Results First Posted: December 26, 2017
Last Update Posted: December 26, 2017
Last Verified: November 2017
Keywords provided by BioFire Diagnostics, LLC:
multiplex
polymerase chain reaction
PCR
BioFire Diagnostics
Infectious gastroenteritis
 Diarrheal disease
Emergency department
rapid diagnostics
FilmArray
FilmArray GI Panel
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Gastroenteritis
Disease Attributes
 Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases