NCT06510699 Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial
| NCT ID | NCT06510699 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Queensland |
| Condition | Fungal Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2025-04-14 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 104 participants in total. It began in 2025-04-14 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
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
Contact & Investigator
Jason A Roberts, PhD
PRINCIPAL INVESTIGATOR
The University of Queensland
Frequently Asked Questions
Who can join the NCT06510699 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Fungal Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06510699 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06510699 currently recruiting?
Yes, NCT06510699 is actively recruiting participants. Contact the research team at j.roberts2@uq.edu.au for enrollment information.
Where is the NCT06510699 trial being conducted?
This trial is being conducted at Seattle, United States, Sydney, Australia, Sydney, Australia, Brisbane, Australia and 3 additional locations.
Who is sponsoring the NCT06510699 clinical trial?
NCT06510699 is sponsored by The University of Queensland. The principal investigator is Jason A Roberts, PhD at The University of Queensland. The trial plans to enroll 104 participants.