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NCT06510699 · ClinicalTrials.gov registry record · Phase 2
Pharmacogenomics for Better Treatment of Fungal Infections in Cancer
A Phase 2 study of Infectious Disease and Blood Cancer, sponsored by The University of Queensland.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
- 7
- Study locations
NCT06510699: Recruiting Phase 2 study of Infectious Disease and Blood Cancer, sponsored by The University of Queensland.
NCT06510699 is a Phase 2 study of Infectious Disease and Blood Cancer that is actively recruiting participants, run by The University of Queensland. The registered enrollment target is 104 participants, below the 7,019-participant average among 18 other Infectious Disease trials with a reported enrollment target (99% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06510699, a Phase 2 study of Infectious Disease and Blood Cancer, is actively recruiting participants, sponsored by The University of Queensland.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
- 7
- Study locations
Study Summary
This project aims to address invasive fungal infections in patients with blood cancer, 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.
Primary Outcome
Proportion of patients with measured therapeutic trough voriconazole concentration at Day 9 (+/- 1 day)
Conditions Studied
Interventions
- OTHER genotype-directed dosing with dosing software based on therapeutic drug monitoring
Study Locations (7)
New South Wales
- Sydney Children's Hospital Network - Sydney
- Westmead Hospital - Sydney
Queensland
- Royal Brisbane & Women's Hospital - Brisbane
- Children's Hospital Queensland - South Brisbane
Washington
- Fred Hutchinson Cancer Centre - Seattle
South Australia
- Royal Adelaide Hospital - Adelaide
Victoria
- Peter MacCallum Cancer Centre - Melbourne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2025-04-14 |
| Est. Completion | 2026-09-02 |
| Phase | Phase 2 |
What NCT06510699 shows while recruiting
NCT06510699 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 7,019-participant average among 18 other Infectious Disease trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Infectious Disease appearing as the primary indexed condition, and to 1 intervention - of which genotype-directed dosing with dosing software based on therapeutic drug monitoring is the first listed.
NCT06510699 lists 7 locations in 5 states (New South Wales, Queensland, Washington).
Frequently Asked Questions
What is clinical trial NCT06510699 about?
NCT06510699 is a clinical study titled "Pharmacogenomics for Better Treatment of Fungal Infections in Cancer". This project aims to address invasive fungal infections in patients with blood cancer, 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 v...
What is the current status of trial NCT06510699?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2025-04-14. Estimated completion is 2026-09-02.
What conditions does trial NCT06510699 study?
This clinical trial studies the following conditions: Infectious Disease, Blood Cancer, Fungal Infection, Haematological Malignancy.
What interventions are being tested in trial NCT06510699?
The interventions under investigation include: genotype-directed dosing with dosing software based on therapeutic drug monitoring (OTHER).
Who is sponsoring clinical trial NCT06510699?
This trial is sponsored by The University of Queensland, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06510699 being conducted?
This trial has 7 study locations across Washington, New South Wales, Queensland, South Australia, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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104 12th of 18 higher than 7 of 18 other Infectious Disease trials
participants (enrollment target), bucketed by value
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