Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System

NCT04249375 | Recruiting

• 1 other identifier: H18-01383
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

This project addresses the problem of adverse drug reactions in the three most frequently prescribed therapeutic classes of drugs in children: antibiotics, analgesics, and mental health medications. We will conduct pilot testing of a pharmacogenomic testing panel and study how the tests and generated test results are utilized and understood by physicians, pharmacists, patients and their families.

Conditions

Adverse Drug Reaction (ADR)

Keywords

Pharmacogenomics; Pediatrics; Adverse Drug Reactions

Outcome Measures

Primary Outcomes (1)

• 150 participants on analgesics, anti-infectives and psychotropics will be given pharmacogenomic recommendations for the risk of gene related adverse events prior to or during treatment.

  We will be able to determine the barriers and facilitators of the implementation of the pharmacogenomic service in a health care facility. This will be done by using standardized questionnaires after each pharmacogenomic report is issued. The prescriber and the patient will both answer questions about the utility of the genetic results, the format of the report and the clarity of the content. Results will be recorded and summarized every 25 patients in order to improve the service and the recommendations through the study.

  June 2020

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any individual who is currently on an analgesic, antibiotic and/or mental health medication that is part of the panels.

You may qualify if:

• Participants will be enrolled if they can benefit from pharmacogenomic testing. This means their physician is considering the use of a drug that is part of the panels (analgesics, antibiotics, and mental health medication) or they are already using one.

You may not qualify if:

• Patients who do not speak or understand English.

Sponsors & Collaborators

• University of British Columbia: lead
• Genome British Columbia: collaborator
• Genome Canada: collaborator
• Dynacare Laboratories, Inc.: collaborator

Study Sites (2)

Children's and Women's Health Centre of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples will be retained for genomic analyses.

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Central Study Contacts

Bruce Carleton, PharmD.

CONTACT

604-875-2179; bcarleton@popi.ubc.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pharmaceutical Outcomes Programme

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: January 30, 2020
• Study Start: February 20, 2020
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (2)