Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial
Recruiting now · Phase 2
Conditions studied: Fungal Infection, Haematological Malignancy, Blood Cancer, Infectious Disease
In brief
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.
Key facts
- Study ID
- NCT06510699
- Run by
- The University of Queensland
- People needed
- 104
- Starts
- 2025-04-14
- Expected to finish
- 2027-03-26
- Last updated by the study team
- 2026-04-16
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age ≥ 2 years.
- Written informed consent obtained.
- Decision to prescribe voriconazole.
- Admitted to a trial site, or sufficient outpatient follow-up appointments are feasible
You may not qualify if…
- 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
Where it is running
- Fred Hutchinson Cancer Centre — Seattle, Washington, United States (enrolling)
- Sydney Children's Hospital Network — Sydney, New South Wales, Australia (enrolling)
- Westmead Hospital — Sydney, New South Wales, Australia (enrolling)
- Royal Brisbane & Women's Hospital — Brisbane, Queensland, Australia (enrolling)
- Children's Hospital Queensland — South Brisbane, Queensland, Australia (enrolling)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
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