BioFire Study

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

Study Summary

Children presenting for Emergency Department (ED) care with bloody diarrhea (i.e. hematochezia) represent a diagnostic challenge. Infectious enteric pathogens – Salmonella, Shigella and Shiga toxin-producing Escherichia coli (STEC) – are at the top of the differential diagnosis list. STEC is of greatest concern because ~15% of infected children develop the Hemolytic Uremic Syndrome (HUS). Our team has demonstrated that antibiotic administration to STEC-infected children increases the risk of developing HUS while dehydration is associated with mortality. Rapidly identifying children with STEC infection can reduce unnecessary resource use in uninfected children while providing them to those with confirmed STEC infection. We will conduct a prospective ED-based study that will randomly allocate 60 children to either standard care as dictated by the treating physician or to the use of a 22-pathogen, nucleic acid based, 1-hour run time diagnostic test. We will evaluate the impact of testing on clinical resource use, clinical outcomes, costs and patient satisfaction. 

Objectives

  1. To determine if use of the BioFire FilmArray in children with hematochezia results in a reduction in resource utilization
  2. To quantify clinical outcomes: development of HUS, acute kidney injury, need for renal replacement therapy, turnaround time from BioFire result relative to stool culture result
  3. To determine if use of the BioFire FilmArray is associated with greater family satisfaction with care
  4. To determine testing criteria to optimize the clinical improvement emerging from use of the BioFire FilmArray (i.e. predictors of bacterial etiology)

Principal Study Investigator: Dr. Stephen Freedman

Project Lead: Kelly Kim

Study Team: Dr. Otto Vanderkooi, Dr. Byron Berenger, Dr. Angelo Mikrogianakis, Dr. Silviu Grisaru, Dr. Susan Samuel, Dr. Dan Gregson, Dr. Linda Chui, Dr. Gillian Currie, Dr. Brent Hagel