Status:
COMPLETED
Improvements Through the Use of a Rapid Multiplex PCR Enteric Pathogen Detection Kit in Children With Hematochezia
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
BioMérieux
Conditions:
Diarrhea Bloody
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief 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-pr...
Detailed Description
Background: The rapid identification of STEC-infected children will enable the provision of appropriate and timely care to such children. The rapid identification of other enteric pathogens (bacteria...
Eligibility Criteria
Inclusion
- Be aged 6 months - 17.99 years of age
- Have ≥3 episodes of diarrhea within the preceding 24 hours and have blood identified in the stool (by physician, nurse or parent)
Exclusion
- Previously enrolled in the study
- Unavailable for Day 14 follow-up
- Currently (most recent complete blood count) known to be neutropenic (Neutrophils \<1000), or at high-risk of being neutropenic (receiving chemotherapy) at present
- Blood work performed prior to enrollment
- Known to be STEC positive (stool culture, PCT, or toxin)
- Pre-existing diagnosis of IBD (Crohn's disease, Ulcerative Colitis)
- Language barrier that prevents the ability to obtain informed consent and assent (when appropriate)
Key Trial Info
Start Date :
June 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03362970
Start Date
June 15 2018
End Date
June 4 2022
Last Update
June 25 2024
Active Locations (1)
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1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8