NCT02248285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,545

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 26, 2017

Completed
Last Updated

December 26, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

September 18, 2014

Results QC Date

October 16, 2017

Last Update Submit

November 29, 2017

Conditions

Infectious Gastroenteritis

Keywords

multiplexpolymerase chain reactionPCRBioFire DiagnosticsInfectious gastroenteritisDiarrheal diseaseEmergency departmentrapid diagnosticsFilmArrayFilmArray GI Panel

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Pre-intervention

NO INTERVENTION

Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.

Interventions

FilmArray™ Gastrointestinal (GI) PanelDEVICE

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

Intervention

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Brown University, Lifespan

Providence, Rhode Island, 02903, United States

Location

University of Utah, Primary Children's Hospital

Salt Lake City, Utah, 84132, United States

Location

Related Publications (3)

  • 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.

    PMID: 22039434BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 38097379DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Director of Clinical Affairs
Organization
BioFire Diagnostics
kevin.bourzac@biofiredx.com
8017366354

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2014

First Posted

September 25, 2014

Study Start

April 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

December 26, 2017

Results First Posted

December 26, 2017

Record last verified: 2017-11

Locations

US(5)