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RecruitingAccepts healthy volunteersPhase 2

Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial

The University of Queensland · with Metro North Hospital and Health Service, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium · NCT06510699

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
104
US sites recruiting
1
Study start
April 14, 2025
Record last updated
April 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: genotype-directed dosing with dosing software based on therapeutic drug monitoring

Conditions: Fungal Infection; Haematological Malignancy; Blood Cancer; Infectious Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Fred Hutchinson Cancer Centre

    Seattle, WA 908109-1024

    Site contact: Ashleigh Miller · 206-667-1994 · amiller3@fredhutch.org

Study contacts (from the official record)

  • Jason A Roberts, PhD · +61 7 3346 5032 · j.roberts2@uq.edu.au
  • Luminita Vlad · 61 7 3346 5045 · l.vlad@uq.edu.au
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Pharmacogenomics for Better Treatment of Fungal Infections… (NCT06510699) | Bored Studies