Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial

This study is looking at a new way to treat serious fungal infections in people with blood cancers. It's testing if adjusting the dose of an anti-fungal medicine called voriconazole based on your genes (pharmacogenomics) and special software can help more patients get the right amount of medicine in their body. This approach aims to make sure the voriconazole dose is just right for you. The study will compare this precision dosing to the usual way voriconazole is given. We want to see if this new method helps more patients reach the correct level of voriconazole by day 8 of treatment. This study is currently recruiting at least 104 children and adults. To join, you must be at least 2 years old, have a fungal infection, and be prescribed voriconazole. You cannot join if you recently had a certain type of stem cell transplant without prior DNA information, or if you are expected to pass away within 7 days.

Study design
This is an interventional study that will randomly assign participants to either receive standard care or precision care. At least 104 children and adults will participate.
What's involved
If you join, you will have blood samples taken on several days (Days 1, 2, 5, 9, 15, and 22) for genotype testing and to measure voriconazole levels. Your voriconazole dose may be adjusted based on these results.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at Day 8, but blood sampling and dose adjustments continue until Day 22.

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NCT06510699

Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial

Recruiting
PHASE2Ages 2+InterventionalTreatment
The University of Queensland
~104 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:genotype-directed dosing with dosing software based on therapeutic drug monitoring

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Therapeutic trough voriconazole concentration at Day 8
Measured over Day 8
Fungal Infection
Haematological Malignancy
Blood Cancer
Infectious Disease
7 sites across 5 states
New South Wales2
Queensland2
Washington1
South Australia1
Victoria1
  • Jason A Roberts, PhD · PRINCIPAL_INVESTIGATOR · The University of Queensland

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Eligibility criteria

Inclusion

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

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
  • Therapeutic trough voriconazole concentration at Day 8Day 8

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