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

NCT03362970 | Completed Results FDA Device

• 1 other identifier: REB17-1916
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea Bloody

Keywords

Bloody Diarrhea; STEC; Hematochezia; BioFire FilmArray; Child

Outcome Measures

Primary Outcomes (1)

• Blood Test Performance

  Any blood testing performed within 72 hours of randomization.

  Day 28 of the study after baseline

Secondary Outcomes (10)

• Intravenous Fluid Administration

  Day 28 of the study after baseline

• Total Physician Visits (ED and Non-ED)

  Day 28 of the study after baseline

• ED Length of Stay

  Day 28 of the study after baseline

• Antibiotic Use

  Day 28 of the study after baseline

• Hospital and Intensive Care Unit Admission

  Day 28 of the study after baseline

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

BioFire Gastrointestinal Panel FilmArray

EXPERIMENTAL

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®

Interventions

BioFire Gastrointestinal Panel FilmArray® DEVICE

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.

BioFire Gastrointestinal Panel FilmArray

Standard of Care OTHER

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.

Standard of Care

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead
• BioMérieux: collaborator

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Related Publications (5)

• Ake JA, Jelacic S, Ciol MA, Watkins SL, Murray KF, Christie DL, Klein EJ, Tarr PI. Relative nephroprotection during Escherichia coli O157:H7 infections: association with intravenous volume expansion. Pediatrics. 2005 Jun;115(6):e673-80. doi: 10.1542/peds.2004-2236.

  PMID: 15930195 BACKGROUND

• Hickey CA, Beattie TJ, Cowieson J, Miyashita Y, Strife CF, Frem JC, Peterson JM, Butani L, Jones DP, Havens PL, Patel HP, Wong CS, Andreoli SP, Rothbaum RJ, Beck AM, Tarr PI. Early volume expansion during diarrhea and relative nephroprotection during subsequent hemolytic uremic syndrome. Arch Pediatr Adolesc Med. 2011 Oct;165(10):884-9. doi: 10.1001/archpediatrics.2011.152. Epub 2011 Jul 22.

  PMID: 21784993 BACKGROUND

• Klein EJ, Boster DR, Stapp JR, Wells JG, Qin X, Clausen CR, Swerdlow DL, Braden CR, Tarr PI. Diarrhea etiology in a Children's Hospital Emergency Department: a prospective cohort study. Clin Infect Dis. 2006 Oct 1;43(7):807-13. doi: 10.1086/507335. Epub 2006 Aug 22.

  PMID: 16941358 BACKGROUND

• Klein EJ, Stapp JR, Clausen CR, Boster DR, Wells JG, Qin X, Swerdlow DL, Tarr PI. Shiga toxin-producing Escherichia coli in children with diarrhea: a prospective point-of-care study. J Pediatr. 2002 Aug;141(2):172-7. doi: 10.1067/mpd.2002.125908.

  PMID: 12183710 BACKGROUND

• Werber D, Mason BW, Evans MR, Salmon RL. Preventing household transmission of Shiga toxin-producing Escherichia coli O157 infection: promptly separating siblings might be the key. Clin Infect Dis. 2008 Apr 15;46(8):1189-96. doi: 10.1086/587670.

  PMID: 18444854 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Stephen Freedman
• Organization: University of Calgary

stephen.freedman@ahs.ca

403-955-7740

Study Officials

• Stephen Freedman, MDCM, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data extractors and Investigators will be unaware of allocation assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 5, 2017
• Study Start: June 15, 2018
• Primary Completion: May 7, 2022
• Study Completion: June 4, 2022
• Last Updated: June 25, 2024
• Results First Posted: June 25, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)