Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System

NCT ID: NCT04249375

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-20

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Adverse Drug Reaction (ADR)

Keywords

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Pharmacogenomics Pediatrics Adverse Drug Reactions

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genome British Columbia

INDUSTRY

Sponsor Role collaborator

Genome Canada

OTHER

Sponsor Role collaborator

Dynacare Laboratories, Inc.

UNKNOWN

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Bruce Carleton

Director, Pharmaceutical Outcomes Programme

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Vancouver, British Columbia, Canada

Site Status RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Bruce Carleton, PharmD.

Role: CONTACT

Phone: 604-875-2179

Email: [email protected]

Facility Contacts

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Bruce Carleton, PharmD.

Role: primary

Related Links

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Other Identifiers

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H18-01383

Identifier Type: -

Identifier Source: org_study_id