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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
Sponsor:
Collaborator:
BioMérieux
Information provided by (Responsible Party):
University of Calgary

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-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.

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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Blood test performance [ Time Frame: Day 28 of the study after baseline ]
    Any blood testing performed within 72 hours of randomization.


Secondary Outcome Measures :
  1. Intravenous fluid administration [ Time Frame: Day 28 of the study after baseline ]
    Children administered IV fluids identified by chart review.

  2. 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.

  3. ED length of stay [ Time Frame: Day 28 of the study after baseline ]
    ED length of stay during enrollment visit determined by chart review.

  4. Antibiotic use [ Time Frame: Day 28 of the study after baseline ]
    Antibiotic use identified by chart review.

  5. Hospital and intensive care unit admission [ Time Frame: Day 28 of the study after baseline ]
    Hospitalization identified by chart review.

  6. Diagnostic imaging performed [ Time Frame: Day 28 of the study after baseline ]
    Diagnostic imaging performed identified by chart review.

  7. Hemolytic-Uremic Syndrome (HUS) [ Time Frame: Day 28 of the study after baseline ]
    Children with HUS identified by chart review.

  8. Acute kidney injury [ Time Frame: Day 28 of the study after baseline ]
    Based on chart review in accordance with KDIGO guidelines.

  9. Need for renal replacement therapy [ Time Frame: Day 28 of the study after baseline ]
    Renal replacement therapy identified by chart review.

  10. 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.



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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be aged 6 months - 17.99 years of age
  2. Have ≥3 episodes of diarrhea within the preceding 24 hours and have blood identified in the stool (by physician, nurse or parent)

Exclusion Criteria:

  1. Previously enrolled in the study
  2. Unavailable for Day 14 follow-up
  3. Currently (most recent complete blood count) known to be neutropenic (Neutrophils <1000), or at high-risk of being neutropenic (receiving chemotherapy) at present
  4. Blood work performed prior to enrollment
  5. Known to be STEC positive (stool culture, PCT, or toxin)
  6. Pre-existing diagnosis of IBD (Crohn's disease, Ulcerative Colitis)
  7. Language barrier that prevents the ability to obtain informed consent and assent (when appropriate)

Information from the National Library of Medicine

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


Contacts
Contact: Stephen Freedman, MDCM, MSc 4039557740 stephen.freedman@albertahealthservices.ca
Contact: Karen Lowerison 4039553197 karen.lowerison@albertahealthservices.ca

Locations
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Stephen Freedman, MDCM, MSc    403-955-7740    stephen.freedman@ahs.ca   
Sponsors and Collaborators
University of Calgary
BioMérieux
Investigators
Principal Investigator: Stephen Freedman, MDCM, MSc University of Calgary

Publications:
Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03362970     History of Changes
Other Study ID Numbers: REB17-1916
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Calgary:
Bloody Diarrhea
STEC
Hematochezia
BioFire FilmArray
Child

Additional relevant MeSH terms:
Diarrhea
Gastrointestinal Hemorrhage
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
Pathologic Processes