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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System
- ClinicalTrials.gov ID
- NCT04249375
- Acronym / sponsor ID
- H18-01383
- Conditions
- Adverse Drug Reaction (ADR)
- Keywords
- Pharmacogenomics, Pediatrics, Adverse Drug Reactions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Genome British Columbia, Genome Canada, Dynacare Laboratories, Inc.
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who do not speak or understand English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Reaction (ADR), run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruce Carleton, PharmD. (604-875-2179, bcarleton@popi.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.