Improvements Through the Use of a Rapid Multiplex PCR Enteric Pathogen Detection Kit in Children With Hematochezia

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 15, 2018

Primary Completion Date

May 7, 2022

Study Completion Date

June 4, 2022

Conditions
Diarrhea Bloody
Interventions
DEVICE

BioFire Gastrointestinal Panel FilmArray®

The BioFire Gastrointestinal Panel FilmArray® is a multiplexed nucleic acid (NA) based device that simultaneously identifies 22 enteric pathogens. It specifically tests for the presence of Shiga toxin and for O157. It requires 2 minutes of hands-on-time, returns results in \~2-3 hour, and is Health Canada and Food and Drug Administration approved. The device, which has been validated, hopefully will enable the early identification of infected children and initiation (or withholding) of interventions directed by previously unavailable clinical data. It will enable us to bring a precision medicine approach into ED care.

OTHER

Standard of Care

Standard practices for children with hematochezia upon the discretion of the treating physician. If investigations are ordered, results have a turn-around time up to 72 hours.

Trial Locations (1)

T3B 6A8

Alberta Children's Hospital, Calgary

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BioMérieux

INDUSTRY

lead

University of Calgary

OTHER

NCT03362970 - Improvements Through the Use of a Rapid Multiplex PCR Enteric Pathogen Detection Kit in Children With Hematochezia | Biotech Hunter | Biotech Hunter