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NCT06510699RecruitingPhase 2

Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial

Randomized Clinical Trial to Evaluate the Use of Genotype-based Dosing of Voriconazole

Source: ClinicalTrials.gov · Last updated 16 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
104 (estimated)
First submitted
14 Jul 2024
Start date
14 Apr 2025
Primary completion date
1 Sept 2026
Lead sponsor
The University of Queensland
NCT number
NCT06510699

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 104
  • From 14 Apr 2025 to the primary completion date, 1 Sept 2026
  • 7 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Post-allogeneic haematopoietic stem cell transplant (HCT) patient, without access to pre HCT DNA
  • Previously randomised to this trial

Other

  • Death is likely imminent within 7 days.

Who the study is looking for

  • Age ≥ 2 years.
  • Written informed consent obtained.
  • Decision to prescribe voriconazole.
  • Admitted to a trial site, or sufficient outpatient follow-up appointments are feasible

Age in the registry: 2 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital
Coordinator of this site? Confirm its status
AdelaideAustraliaRecruiting
Royal Brisbane & Women's Hospital
Coordinator of this site? Confirm its status
BrisbaneAustraliaRecruiting
Peter MacCallum Cancer Centre
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Children's Hospital Queensland
Coordinator of this site? Confirm its status
South BrisbaneAustraliaRecruiting
Sydney Children's Hospital Network
Coordinator of this site? Confirm its status
SydneyAustraliaRecruiting
Westmead Hospital
Coordinator of this site? Confirm its status
SydneyAustraliaRecruiting
Fred Hutchinson Cancer Centre
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.