Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2+
SponsorThe University of Queensland

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 2 years.

Written informed consent obtained.

Decision to prescribe voriconazole.

Admitted to a trial site, or sufficient outpatient follow-up appointments are feasible

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Precision CareExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Therapeutic trough voriconazole concentration at Day 8

Proportion of patients with measured therapeutic trough voriconazole concentration at Day 9 (+/- 1 day)

Time frame
Day 8

Secondary outcomes

1

Simulated therapeutic trough voriconazole exposure at Day 8

Proportion of patients with simulated therapeutic trough voriconazole exposure at Day 8

Time frame
Day 8
2

Measured therapeutic trough voriconazole exposure at Day 14.

Proportion of patients with measured therapeutic trough voriconazole exposure at Day 14.

Time frame
Day 14
3

Simulated therapeutic trough voriconazole exposure at Day 14

Proportion of patients with simulated therapeutic trough voriconazole exposure at Day 14

Time frame
Day 14
4

Measured therapeutic trough voriconazole exposure at both Days 8 and 14

Proportion of patients with measured therapeutic trough voriconazole exposure at both Days 8 and 14

Time frame
Days 8 and 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Queensland

Lead sponsor

Metro North Hospital and Health Service

Collaborator

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Collaborator

University of Sydney

Collaborator

Western Sydney Local Health District

Collaborator

Sydney Children's Hospitals Network

Collaborator

Peter MacCallum Cancer Centre, Australia

Collaborator

University of Melbourne

Collaborator

Royal Adelaide Hospital

Collaborator

Pathology Queensland

Collaborator

Royal Brisbane and Women's Hospital

Collaborator

Lady Cilento Children's Hospital, Brisbane

Collaborator