Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial
Randomized Clinical Trial to Evaluate the Use of Genotype-based Dosing of Voriconazole
The University of Queensland
104 participants
Apr 14, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Age ≥ 2 years.
- Written informed consent obtained.
- Decision to prescribe voriconazole.
- Admitted to a trial site, or sufficient outpatient follow-up appointments are feasible
Exclusion Criteria3
- 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
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Interventions
Genotype-directed dosing with dosing software based on therapeutic drug monitoring
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT06510699