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
- Diseases
- Childhood cancers
- 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
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Royal Brisbane & Women's Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Children's Hospital Queensland Coordinator of this site? Confirm its status | South Brisbane | Australia | Recruiting |
| Sydney Children's Hospital Network Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Westmead Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Fred Hutchinson Cancer Centre Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.