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Pharmacogenomics for Better Treatment of Fungal Infections in Cancer
Sponsor: The University of Queensland
Summary
This project aims to address invasive fungal infections in patients with blood cancer, by precision dosing of voriconazole based on CYP2C19 genotype testing with Bayesian dose-forecasting dosing software to develop patient-centric and maximally effective dosing regimens. This study investigates if voriconazole increases the proportion of patients achieving therapeutic exposure at day 8 of dosing compared with standard care; and will assess factors that influence the implementation of genotype testing and dosing software in the healthcare system, including fidelity, feasibility, acceptability and cost-effectiveness. It will recruit at least 104 kids and adults in a parallel-group randomised clinical trial. A hybrid feasibility sub-study will assess the scalability of genotype-directed dosing to ensure sustainable integration of the interventions into the clinical workflow. A health economic sub-study will evaluate the costs, health outcomes and cost-effectiveness of genotype-directed testing compared to standard care.
Official title: Randomized Clinical Trial to Evaluate the Use of Genotype-based Dosing of Voriconazole in Patients With Haematological Malignancy
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2025-04-14
Completion Date
2026-09-02
Last Updated
2025-11-19
Healthy Volunteers
No
Interventions
genotype-directed dosing with dosing software based on therapeutic drug monitoring
Genotype-directed dosing with dosing software based on therapeutic drug monitoring
Locations (7)
Fred Hutchinson Cancer Centre
Seattle, Washington, United States
Sydney Children's Hospital Network
Sydney, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Royal Brisbane & Women's Hospital
Brisbane, Queensland, Australia
Children's Hospital Queensland
South Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia