Pharmacogenomics to improve voriconazole dosing for fungal infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, parallel-group Phase 2 trial will compare standard care dosing and therapeutic drug monitoring of voriconazole with a precision-care approach that adds CYP2C19 genotype results and Bayesian dose-forecasting software to guide dose adjustments. Participants aged 2 years and older who are starting voriconazole will be randomized to standard or genotype-directed dosing and will have blood sampling for therapeutic drug monitoring and genotype testing. Dose adjustments for the precision group will be guided by the dosing software on Days 5, 9, 15 and 22, while the standard group will follow usual clinical practice. The trial includes a hybrid feasibility sub-study to assess implementation and a health economic sub-study to estimate costs and cost-effectiveness, aiming to recruit at least 104 children and adults.

Why it matters

Who can join: the full rules

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

Where it's running

• Fred Hutchinson Cancer Centre
  Seattle, Washington, United States Recruiting
• Sydney Children's Hospital Network
  Sydney, New South Wales, Australia Recruiting
• Westmead Hospital
  Sydney, New South Wales, Australia Recruiting
• Royal Brisbane & Women's Hospital
  Brisbane, Queensland, Australia Recruiting
• Children's Hospital Queensland
  South Brisbane, Queensland, Australia Recruiting
• Royal Adelaide Hospital
  Adelaide, South Australia, Australia Recruiting

Study contacts

• Principal investigator: Jason A Roberts, PhD — The University of Queensland
• Study coordinator: Jason A Roberts, PhD
• Email: j.roberts2@uq.edu.au
• Phone: +61 7 3346 5032

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.