N/A
N=60
Improvements Through the Use of a Rapid Multiplex PCR Enteric Pathogen Detection Kit in Children With Hematochezia
Diarrhea Bloody
Bottom Line
View on ClinicalTrials.gov: NCT03362970 ↗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
| Outcome | Result | p-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)
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.