Pharmacogenomics for Better Treatment of Fungal Infections Clinical 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 o
| Condition(s) | Fungal Infection, Haematological Malignancy, Blood Cancer, Infectious Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 sustai |
| Who can participate | Inclusion Criteria: * Age ≥ 2 years. * Written informed consent obtained. * Decision to prescribe voriconazole. * Admitted to a trial site, or sufficient outpatient follow-up appointments are feasible Exclusion Criteria: * 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 |
| Ages | 2 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | The University of Queensland |
| Locations | Seattle, Washington, United States; Sydney, New South Wales, Australia; Sydney, New South Wales, Australia; Brisbane, Queensland, Australia; South Brisbane, Queensland, Australia; Adelaide, South Australia, Australia (+1 more sites) |
| Start date | 2025-04-14 |
| NCT ID | NCT06510699 |
| Official listing | https://clinicaltrials.gov/study/NCT06510699 |