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NCT Number: NCT04249375

Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's and Women's Health Centre of British Columbia, Vancouver, British Columbia, Canada

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About this study

The specific objectives are to:

  • Implement a pilot pharmacogenomics program to test medication safety and effectiveness of antibiotics, analgesics and mental health medication to enhance prescribing decision-making.
  • Develop data collection forms to collect necessary patient information from the prescribing physicians.
  • Develop pharmacogenomics reports to return results to physicians, pharmacists, patients and their families.
  • Determine how the tests and results are perceived and utilized by physicians, pharmacists, patients and their families.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

    Time frame: June 2020

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bruce Carleton, PharmD.

CONTACT

[email protected]

604-875-2179

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Dynacare Laboratories, Inc.
  • Genome British Columbia
  • Genome Canada

Registry information

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Jan 30, 2020
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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