Adverse Drug Reaction (ADR)NCT04249375
Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System
An observational study of Adverse Drug Reaction (ADR), run by University of British Columbia at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Drug Reaction (ADR)
- How many people
- 150 participants
- Where
- 2 sitesCanada
- Study dates
- 20 Feb 2020to Mar 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any individual who is currently on an analgesic, antibiotic and/or mental health medication that is part of the panels.
Who may be able to join
- 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.
Who cannot join
- Patients who do not speak or understand English.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
- Recruiting
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3V4
Bruce Carleton, PharmD., 604-875-2179, bcarleton@popi.ubc.ca
About this study
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.
Read the detailed description
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.
- Conditions
- Adverse Drug Reaction (ADR)
- Keywords
- Pharmacogenomics, Pediatrics, Adverse Drug Reactions
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: June 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start20 Feb 2020
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug Reaction (ADR)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Genome British Columbia, Genome Canada, Dynacare Laboratories, Inc.
- Responsible party
- Principal investigator, Bruce Carleton, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249375
- Sponsor's protocol ID
- H18-01383
- Status last verified
- Apr 2026
- First submitted
- 24 Sep 2019
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No