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

Infectious Gastroenteritis Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248285
• Other study ID #: DX-SDY-019839
• Secondary ID: R01AI104593
• Status: Completed
• Phase: N/A
• First received: September 18, 2014
• Last updated: November 29, 2017
• Start date: April 2015
• Est. completion date: August 2016

Study information

• Verified date: November 2017
• Source: BioFire Diagnostics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1545
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Gastroenteritis
• Infection
• Infectious Gastroenteritis

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
BioFire Diagnostics, LLC	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (2)

FDA. FDA clearance for FilmArray Gastrointestinal Panel, May 2, 2014. http://www.accessdata.fda.gov/cdrh_docs/reviews/K140407.pdf (2014).

Poritz MA, Blaschke AJ, Byington CL, Meyers 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. Erratum in: PLoS One. 2011;6(11). doi: 10.1371/annotation/468cfdcd-184c-42f7-a1d0-3b72a2f6a558. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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