Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

genotype-directed dosing with dosing software based on therapeutic drug monitoring: Genotype-directed dosing with dosing software based on therapeutic drug monitoring

Study summary

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.

Eligibility

Primary outcome measure(s)

• Therapeutic trough voriconazole concentration at Day 8 — Day 8
  Proportion of patients with measured therapeutic trough voriconazole concentration at Day 9 (+/- 1 day)

Trial sites (7)

More The University of Queensland trials in Australia

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