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Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial

RecruitingPhase 2Ages 2 Years - anyAllThe University of Queensland
NCT06510699 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 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
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What it tests

  • genotype-directed dosing with dosing software based on therapeutic drug monitoring
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Where

7 sites
Fred Hutchinson Cancer Centre
Seattle, United States
Sydney Children's Hospital Network
Sydney, Australia
Westmead Hospital
Sydney, Australia
Royal Brisbane & Women's Hospital
Brisbane, Australia
Children's Hospital Queensland
South Brisbane, Australia
Royal Adelaide Hospital
Adelaide, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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