Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System

Adverse Drug Reaction (ADR) Clinical Trial

Official title:

Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04249375
• Other study ID #: H18-01383
• Status: Recruiting
• Start date: February 20, 2020
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: University of British Columbia
• Contact: Bruce Carleton, PharmD.
• Phone: 604-875-2179
• Email: bcarleton[@]popi.ubc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The specific objectives are to:

1. Implement a pilot pharmacogenomics program to test medication safety and effectiveness of antibiotics, analgesics and mental health medication to enhance prescribing decision-making.

2. Develop data collection forms to collect necessary patient information from the prescribing physicians.

3. Develop pharmacogenomics reports to return results to physicians, pharmacists, patients and their families.

4. Determine how the tests and results are perceived and utilized by physicians, pharmacists, patients and their families.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients who do not speak or understand English.

Related Conditions & MeSH terms

• Adverse Drug Reaction (ADR)
• Drug-Related Side Effects and Adverse Reactions

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Children's and Women's Health Centre of British Columbia	Vancouver	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of British Columbia	Dynacare Laboratories, Inc., Genome British Columbia, Genome Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Project Info
•   Related Info