Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial

Part of paid clinical trials in Seattle, Washington.

Sponsor
The University of Queensland
Study ID
NCT06510699
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Blood Cancer
  • Fungal Infection
  • Haematological Malignancy
  • Infectious Disease

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • genotype-directed dosing with dosing software based on therapeutic drug monitoring — OTHER
    Genotype-directed dosing with dosing software based on therapeutic drug monitoring

Study Details

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 Dates

Start date
Apr 14, 2025
Status verified
Oct 2025
Primary completion
Sep 1, 2026
Completion
Mar 26, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutchinson Cancer CentreSeattleWashington908109-1024
Ashleigh Miller
[email protected]
206-667-1994
Catherine Professor Liu, MD
[email protected]
206-667-2729

Find similar trials in Seattle, WA

By research site
Fred Hutchinson Cancer Centre· Seattle, WA

Related Studies