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Nucleic Acid-Based Test

BioFire Gastrointestinal Panel FilmArray® for Bloody Diarrhea

N/A
Waitlist Available
Led By Stephen Freedman, MDCM, MSc
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28 of the study after baseline
Awards & highlights

Study Summary

This trial will test whether a 1-hour diagnostic test can help identify which children presenting to the emergency department with bloody diarrhea have a bacterial infection that could lead to serious complications.

Eligible Conditions
  • Bloody Diarrhea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28 of the study after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 of the study after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood test performance
Secondary outcome measures
Acute kidney injury
Antibiotic use
Caregiver and Patient Satisfaction
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BioFire Gastrointestinal Panel FilmArrayExperimental Treatment1 Intervention
For children randomized to the BioFire FilmArray arm, stool, if available, will be sent STAT to Calgary Laboratory Services (CLS) for the performance of the BioFire FilmArray test and routine culture. If stool is unavailable, a rectal swab will be performed and sent to CLS for the performance of the BioFire FilmArray test and routine culture. A routine stool specimen for back-up culture will still be requested as per standard of care once it is available. Treatment decisions will be at the sole discretion of the ED treating physician who receives the result.
Group II: Standard of CareActive Control1 Intervention
For children randomized to the standard of care arm, the treating physician will be informed to proceed as per their usual practice and treatment patterns. If stool is unavailable a rectal swab will be collected and sent to Calgary Laboratory Services (CLS) for routine culture. A routine stool specimen for back-up culture will still be requested as per standard of care. Home stool collection will be performed for those unable to provide a sample at enrolment and will be achieved by providing families with collection kits.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BioFire Gastrointestinal Panel FilmArray®
2018
N/A
~60

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
791 Previous Clinical Trials
868,674 Total Patients Enrolled
BioMérieuxIndustry Sponsor
58 Previous Clinical Trials
42,170 Total Patients Enrolled
Stephen Freedman, MDCM, MScPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
6,800 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Clinical Infectious DiseasesJournal
Diarrhea Etiology in a Children’s Hospital Emergency Department: A Prospective Cohort Study
Klein, Eileen J., Daniel R. Boster, Jennifer R. Stapp, Joy G. Wells, Xuan Qin, Carla R. Clausen, David L. Swerdlow, Christopher R. Braden, and Phillip I. Tarr. 2006. “Diarrhea Etiology in a Children’s Hospital Emergency Department: A Prospective Cohort Study”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1086/507335.
The Journal of PediatricsJournal
Shiga Toxin-producing Escherichia Coli in Children with Diarrhea: A Prospective Point-of-care Study
Klein, Eileen J., Jennifer R. Stapp, Carla R. Clausen, Daniel R. Boster, Joy G. Wells, Xuan Qin, David L. Swerdlow, and Phillip I. Tarr. 2002. “Shiga Toxin-producing Escherichia Coli in Children with Diarrhea: A Prospective Point-of-care Study”. The Journal of Pediatrics. Elsevier BV. doi:10.1067/mpd.2002.125908.
escherichia ColiJournal
Preventing Household Transmission of Shiga Toxin–producing<i>escherichia Coli</i>o157 Infection: Promptly Separating Siblings Might Be the Key
Werber, Dirk, Brendan W. Mason, Meirion R. Evans, and Roland L. Salmon. 2008. “Preventing Household Transmission of Shiga Toxin–producingescherichia Colio157 Infection: Promptly Separating Siblings Might Be the Key”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1086/587670.
Archives of Pediatrics & Adolescent MedicineJournal
Early Volume Expansion During Diarrhea and Relative Nephroprotection During Subsequent Hemolytic Uremic Syndrome
Hickey, Christina A.. 2011. “Early Volume Expansion During Diarrhea and Relative Nephroprotection During Subsequent Hemolytic Uremic Syndrome”. Archives of Pediatrics & Adolescent Medicine. American Medical Association (AMA). doi:10.1001/archpediatrics.2011.152.
~9 spots leftby Apr 2025
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