NCT03362970

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

Completed NA Results posted Last updated 25 June 2024

What this trial tests

NA trial testing BioFire Gastrointestinal Panel FilmArray® in Diarrhea Bloody in 60 participants. Completed in 4 June 2022.

Timeline

15 June 2018

Primary endpoint
7 May 2022

4 June 2022

Quick facts

Lead sponsor	University of Calgary
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	60
Start date	15 June 2018
Primary completion	7 May 2022
Estimated completion	4 June 2022
Sites	1 location across Canada

Drugs / interventions tested

• BioFire Gastrointestinal Panel FilmArray®
• Standard of Care

Conditions studied

• Diarrhea Bloody — all drugs for Diarrhea Bloody →

Sponsor

University of Calgary

Who can join

Adults 6 Months to 18, any sex, with Diarrhea Bloody. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Blood Test Performance Primary · Day 28 of the study after baseline

Any blood testing performed within 72 hours of randomization.

Group	Value	95% CI
Standard of Care	18
BioFire Gastrointestinal Panel FilmArray	17

Intravenous Fluid Administration Secondary · Day 28 of the study after baseline

Children administered IV fluids identified by chart review.

Group	Value	95% CI
Standard of Care	12
BioFire Gastrointestinal Panel FilmArray	11

Total Physician Visits (ED and Non-ED) Secondary · Day 28 of the study after baseline

Children visiting additional health-care practitioners identified by chart review.

Group	Value	95% CI
Standard of Care	1	0 – 1
BioFire Gastrointestinal Panel FilmArray	0	0 – 1

ED Length of Stay Secondary · Day 28 of the study after baseline

ED length of stay during enrollment visit determined by chart review.

Group	Value	95% CI
Standard of Care	4.2	2.9 – 5.6
BioFire Gastrointestinal Panel FilmArray	4.6	3.6 – 5.7

Antibiotic Use Secondary · Day 28 of the study after baseline

Antibiotic use identified by chart review.

Group	Value	95% CI
Standard of Care	5
BioFire Gastrointestinal Panel FilmArray	6

Hospital and Intensive Care Unit Admission Secondary · Day 28 of the study after baseline

Hospitalization identified by chart review.

Group	Value	95% CI
Standard of Care	2
BioFire Gastrointestinal Panel FilmArray	5

Diagnostic Imaging Performed Secondary · Day 28 of the study after baseline

Diagnostic imaging performed identified by chart review.

Group	Value	95% CI
Standard of Care	2
BioFire Gastrointestinal Panel FilmArray	4

Hemolytic-Uremic Syndrome (HUS) Secondary · Day 28 of the study after baseline

Children with HUS identified by chart review.

Group	Value	95% CI
Standard of Care	0
BioFire Gastrointestinal Panel FilmArray	0

Acute Kidney Injury Secondary · Day 28 of the study after baseline

Based on chart review in accordance with KDIGO guidelines.

Group	Value	95% CI
Standard of Care	0
BioFire Gastrointestinal Panel FilmArray	0

Need for Renal Replacement Therapy Secondary · Day 28 of the study after baseline

Renal replacement therapy identified by chart review.

Group	Value	95% CI
Standard of Care	0
BioFire Gastrointestinal Panel FilmArray	0

Caregiver and Patient Satisfaction Secondary · 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. Caregivers were asked the following question: "Using any number from 0 to 10, where 0 is the worst care possible and 10 is the best care possible, what number would you use to rate your child's care during the emergency department visit (Day 0 - Enrollment visit)?" the scale does not have a name or specific construct beyond as detailed in the script that was used to ask the question. The range is from 0 (minimum) to 10 (maximum). There are no sub-scales. Higher values represent greater satisfacti

Group	Value	95% CI
Standard of Care	9	8 – 10
BioFire Gastrointestinal Panel FilmArray	9	8 – 10

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of a Rapid Multiplex Gastrointestinal Panel with Standard Laboratory Testing in the Management of Children with Hematochezia in a Pediatric Emergency Department: Randomized Controlled Trial.
   Xie J, Kim K, Berenger BM, Chui L, et al · · 2023 · cited 7× · PMID 37039648 · DOI 10.1128/spectrum.00268-23