Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial

This project aims to address invasive fungal infections in patients, 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.

NCT Number	NCT06510699
Lead Sponsor	The University of Queensland Collaborators: Metro North Hospital and Health Service, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, University of Sydney, Western Sydney Local Health District, Sydney Children's Hospitals Network, Peter MacCallum Cancer Centre, Australia, University of Melbourne, Royal Adelaide Hospital, Pathology Queensland, Royal Brisbane and Women's Hospital, Lady Cilento Children's Hospital, Brisbane
Conditions	Fungal Infection, Haematological Malignancy, Blood Cancer, Infectious Disease
Enrollment	104 participants
Start Date	2025-04-14
Primary Completion	2026-09-01 (estimated)
Study Completion	2027-03-26 (estimated)
Updated on ClinicalTrials.gov	2026-04-16