Recruiting
Phase 2

Voriconazole

Sponsor:

The University of Queensland

Code:

NCT06510699

Conditions

Fungal Infection

Haematological Malignancy

Blood Cancer

Infectious Disease

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief 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.

Conditions

Fungal Infection

Haematological Malignancy

Blood Cancer

Infectious Disease

Study ID

NCT06510699

Start date

Apr 14, 2025

Status verified date

Oct, 2025

Completion date

Mar 26, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Precision Care

Voriconazole dosing will be initiated using current standard care dosing. Samples for TDM and genotype testing will be collected. Based on the results of these tests on Day 5, 8, 14, and up to day 30 ( ± 1 day) patients will be evaluated for dose adjustment using dosing software that includes patient data including TDM and genotype data.

no intervention: Standard Care

Current standard of care at trial-site institutions uses weight-based (mg/kg) initial dosing of voriconazole, with dose adjustment based on standard therapeutic drug monitoring (TDM) results of measured voriconazole concentrations and based on clinical judgement.

Interventions

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

Genotype-directed dosing with dosing software based on therapeutic drug monitoring

Primary outcome measure

  • Therapeutic trough voriconazole concentration at Day 8 [ Time Frame: Day 8 ]

Central Contacts and Locations

Central contacts

Locations

Fred Hutchinson Cancer Centre

Recruiting

Seattle, Washington, United States, 908109-1024

Contacts

More Information

Sponsor

The University of Queensland

Last update posted

Apr 16, 2026

Last verified

Oct, 2025

Keywords

  • infection
  • cancer
  • pharmacogenomic
  • genotype-based dosing
  • CYP2C19

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Queensland on 2026-04-16.