Status:
COMPLETED
Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study
Lead Sponsor:
BioFire Diagnostics, LLC
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Infectious Gastroenteritis
Eligibility:
All Genders
Up to 18 years
Phase:
NA
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
1545 Patients enrolled
Trial Details
Trial ID
NCT02248285
Start Date
April 1 2015
End Date
August 1 2016
Last Update
December 26 2017
Active Locations (5)
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1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
4
Brown University, Lifespan
Providence, Rhode Island, United States, 02903