Improvements Through the Use of a Rapid Multiplex PCR Enteric Pathogen Detection Kit in Children With Hematochezia
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|ClinicalTrials.gov Identifier: NCT03362970|
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea Bloody||Device: BioFire Gastrointestinal Panel FilmArray® Other: Standard of Care||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Data extractors and Investigators will be unaware of allocation assignment.|
|Primary Purpose:||Health Services Research|
|Official Title:||Improvements Through the Use of a Rapid Multiplex PCR Enteric Pathogen Detection Kit in Children With Hematochezia|
|Actual Study Start Date :||June 5, 2018|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Active Comparator: Standard of Care
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.
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.
Experimental: BioFire Gastrointestinal Panel FilmArray
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.
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.
- Blood test performance [ Time Frame: Day 28 of the study after baseline ]Any blood testing performed within 72 hours of randomization.
- Intravenous fluid administration [ Time Frame: Day 28 of the study after baseline ]Children administered IV fluids identified by chart review.
- Total physician visits (ED and non-ED) [ Time Frame: Day 28 of the study after baseline ]Children visiting additional health-care practitioners identified by chart review.
- ED length of stay [ Time Frame: Day 28 of the study after baseline ]ED length of stay during enrollment visit determined by chart review.
- Antibiotic use [ Time Frame: Day 28 of the study after baseline ]Antibiotic use identified by chart review.
- Hospital and intensive care unit admission [ Time Frame: Day 28 of the study after baseline ]Hospitalization identified by chart review.
- Diagnostic imaging performed [ Time Frame: Day 28 of the study after baseline ]Diagnostic imaging performed identified by chart review.
- Hemolytic-Uremic Syndrome (HUS) [ Time Frame: Day 28 of the study after baseline ]Children with HUS identified by chart review.
- Acute kidney injury [ Time Frame: Day 28 of the study after baseline ]Based on chart review in accordance with KDIGO guidelines.
- Need for renal replacement therapy [ Time Frame: Day 28 of the study after baseline ]Renal replacement therapy identified by chart review.
- Caregiver and Patient Satisfaction [ Time Frame: Day 14 of the study after baseline ]Satisfaction of care received during ED visit answered in Day 14 follow-up form on a Likert scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362970
|Contact: Stephen Freedman, MDCM, MScemail@example.com|
|Contact: Karen Lowerisonfirstname.lastname@example.org|
|Alberta Children's Hospital||Recruiting|
|Calgary, Alberta, Canada, T3B 6A8|
|Contact: Stephen Freedman, MDCM, MSc 403-955-7740 email@example.com|
|Principal Investigator:||Stephen Freedman, MDCM, MSc||University of Calgary|