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RECRUITING
NCT06510699
PHASE2

Pharmacogenomics for Better Treatment of Fungal Infections in Cancer

Sponsor: The University of Queensland

View on ClinicalTrials.gov

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

OTHER

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