Actively Recruiting
Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial
Led by The University of Queensland · Updated on 2026-04-16
104
Participants Needed
7
Research Sites
101 weeks
Total Duration
On this page
Sponsors
T
The University of Queensland
Lead Sponsor
M
Metro North Hospital and Health Service
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 2 years
- Written informed consent obtained
- Decision to prescribe voriconazole
- Admitted to a trial site, or sufficient outpatient follow-up appointments are feasible
You will not qualify if you...
- Post-allogeneic haematopoietic stem cell transplant patient without access to pre-transplant DNA
- Death is likely imminent within 7 days
- Previously randomised to this trial
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Fred Hutchinson Cancer Centre
Seattle, Washington, United States, 908109-1024
Actively Recruiting
2
Sydney Children's Hospital Network
Sydney, New South Wales, Australia, 21452031
Actively Recruiting
3
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Actively Recruiting
4
Royal Brisbane & Women's Hospital
Brisbane, Queensland, Australia, 4029
Actively Recruiting
5
Children's Hospital Queensland
South Brisbane, Queensland, Australia, 4029
Actively Recruiting
6
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
7
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3053
Actively Recruiting
Research Team
J
Jason A Roberts, PhD
CONTACT
L
Luminita Vlad
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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