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N/A N=60 Randomized Double-blind Health Services Research

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

Diarrhea Bloody

Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Blood Test Performance — 18; 17 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
BioFire Gastrointestinal Panel FilmArray® (Device); Standard of Care (Other)
Age
Pediatric, Adult · 0+ yrs
Sex
All
Sponsor
University of Calgary
Primary completion
May 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Blood Test Performance
18; 17
SECONDARY
Intravenous Fluid Administration
12; 11
SECONDARY
Total Physician Visits (ED and Non-ED)
1; 0
SECONDARY
ED Length of Stay
4.2; 4.6
SECONDARY
Antibiotic Use
5; 6
SECONDARY
Hospital and Intensive Care Unit Admission
2; 5
SECONDARY
Diagnostic Imaging Performed
2; 4
SECONDARY
Hemolytic-Uremic Syndrome (HUS)
0; 0
SECONDARY
Acute Kidney Injury
0; 0
SECONDARY
Need for Renal Replacement Therapy
0; 0
SECONDARY
Caregiver and Patient Satisfaction
9; 9

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. The study team 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. The study team will evaluate the impact of testing on clinical resource use, clinical outcomes, costs and patient satisfaction.

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03362970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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