Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study
NCT ID: NCT02248285
Last Updated: 2017-12-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
1545 participants
INTERVENTIONAL
2015-04-30
2016-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
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
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.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
BioFire Diagnostics, LLC
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Poritz MA, Blaschke AJ, Byington CL, Allen L, Nilsson K, Jones DE, Thatcher SA, Robbins T, Lingenfelter B, Amiott E, Herbener A, Daly J, Dobrowolski SF, Teng DH, Ririe KM. FilmArray, an automated nested multiplex PCR system for multi-pathogen detection: development and application to respiratory tract infection. PLoS One. 2011;6(10):e26047. doi: 10.1371/journal.pone.0026047. Epub 2011 Oct 19.
FDA. FDA clearance for FilmArray Gastrointestinal Panel, May 2, 2014. http://www.accessdata.fda.gov/cdrh_docs/reviews/K140407.pdf (2014).
Pavia AT, Cohen DM, Leber AL, Daly JA, Jackson JT, Selvarangan R, Kanwar N, Bender JM, Dien Bard J, Festekjian A, Duffy S, Larsen C, Holmberg KM, Bardsley T, Haaland B, Bourzac KM, Stockmann C, Chapin KC, Leung DT. Clinical Impact of Multiplex Molecular Diagnostic Testing in Children With Acute Gastroenteritis Presenting to an Emergency Department: A Multicenter Prospective Study. Clin Infect Dis. 2024 Mar 20;78(3):573-581. doi: 10.1093/cid/ciad710.
Other Identifiers
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DX-SDY-019839
Identifier Type: -
Identifier Source: org_study_id