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Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial

Study acronym: PRAGMATIC
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 16, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Jun 1, 2026 to Sep 1, 2026
    • Study completion date: Sep 2, 2026 to Mar 26, 2027
    • Eligibility criteria shortened, about 6 words
    • Study title revised
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2024 to Apr 14, 2025
    • Site details revised at 7 of 7 sites
    • Collaborators revised (11)
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06510699
Lead Sponsor The University of Queensland
Collaborators: Metro North Hospital and Health Service, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, University of Sydney, Western Sydney Local Health District, Sydney Children's Hospitals Network, Peter MacCallum Cancer Centre, Australia, University of Melbourne, Royal Adelaide Hospital, Pathology Queensland, Royal Brisbane and Women's Hospital, Lady Cilento Children's Hospital, Brisbane
Conditions
(from sponsor)		 Fungal Infection, Haematological Malignancy, Blood Cancer, Infectious Disease
Related terms Communicable Diseases, Hematologic Neoplasms, Infections, Mycoses, Neoplasms
Enrollment 104 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov