Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial

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

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

Interventions

OTHER

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

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

Sponsors & Collaborators

• Metro North Hospital and Health Service

  collaborator UNKNOWN

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  collaborator OTHER

• University of Sydney

  collaborator OTHER

• Western Sydney Local Health District

  collaborator OTHER

• Sydney Children's Hospitals Network

  collaborator OTHER

• Peter MacCallum Cancer Centre, Australia

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• Royal Adelaide Hospital

  collaborator OTHER

• Pathology Queensland

  collaborator UNKNOWN

• Royal Brisbane and Women's Hospital

  collaborator OTHER_GOV

• Lady Cilento Children's Hospital, Brisbane

  collaborator OTHER

• The University of Queensland

  lead OTHER

Principal Investigators

• Jason A Roberts, PhD · The University of Queensland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-04-14

Primary Completion

2026-09-01

Completion

2027-03-26

FDA Drug

Yes

Countries

• United States
• Australia

Study Locations