Pharmacogenomics for Better Treatment of Fungal Infections in Cancer
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 2 years. * Written informed consent obtained. * Decision to prescribe voriconazole. * Diagnosed with haematological malignancy or disorder. * Admitted to a trial site, or sufficient outpatient follow-up appointments are feasible Exclusion Criteria: * Post-allogeneic haematopoietic stem cell transplant (HCT) patient, without access to pre HCT DNA * Death is likely imminent within 7 days. * Previously randomised to this trial