Actively Recruiting

Phase 2
Age: 2Years +
All Genders
Healthy Volunteers
NCT06510699

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

Age: 2Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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