Personalized Dosing for Fungal Infections
(PRAGMATIC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method of administering voriconazole, an antifungal medication, to individuals with blood cancer who have serious fungal infections. The goal is to determine if adjusting doses based on a genetic test and special software helps more patients receive the correct amount of medicine by day 8 compared to usual care. The study will also assess the practicality of this approach in real-world healthcare and its cost-effectiveness. Suitable participants include those with blood cancer already prescribed voriconazole. The trial consists of two groups: one receiving standard care and the other undergoing precision dosing with the new method. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It focuses on dosing voriconazole for fungal infections, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that voriconazole is likely to be safe for humans?
Research has shown that voriconazole is usually well-tolerated, though some people may experience side effects. In one study, about 18% of patients had treatment-related reactions. Another study found that adjusting doses based on therapeutic drug monitoring (TDM) can help manage safety. TDM involves checking drug levels in the blood to ensure they remain in the right range, which can better manage the risk of serious reactions.
Voriconazole is already used to treat fungal infections. This trial involves personalized dosing, aiming to enhance safety and effectiveness by tailoring treatment to individual needs.12345Why are researchers excited about this trial's treatment?
Researchers are excited about this trial because it explores a personalized approach to dosing voriconazole for fungal infections. Unlike standard methods, which adjust doses based on weight and routine drug monitoring, this approach incorporates genetic testing and advanced software to tailor dosages more precisely to each patient's unique profile. This could lead to more effective and safer treatments, reducing side effects and improving outcomes by ensuring patients receive the optimal dose faster.
What evidence suggests that voriconazole with precision dosing might be an effective treatment for fungal infections in blood cancer patients?
This trial will compare two approaches to voriconazole dosing for fungal infections. In the Standard Care arm, participants receive weight-based initial dosing of voriconazole, with dose adjustments based on standard therapeutic drug monitoring (TDM) and clinical judgment. In the Precision Care arm, participants also start with standard dosing, but their doses are adjusted using specialized software that incorporates TDM and genotype data. Research has shown that monitoring drug levels can help customize voriconazole treatment for each person. Studies have found that the amount of voriconazole in the blood is linked to treatment effectiveness. By using genetic testing, the dose can be adjusted to fit each patient, potentially improving results. Special tools and software help achieve the right drug levels more reliably. This personalized method aims to make voriconazole more effective against fungal infections, especially in patients with blood cancer.26789
Who Is on the Research Team?
Jason A Roberts, PhD
Principal Investigator
The University of Queensland
Are You a Good Fit for This Trial?
This trial is for kids and adults with blood cancer who are dealing with invasive fungal infections. Participants must be able to undergo genotype testing, which will guide the dosing of voriconazole treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline and Randomisation
Baseline data collection and randomisation of participants into standard care or precision care groups
Treatment
Participants receive voriconazole with dose adjustments based on TDM and genotype testing
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Voriconazole
Trial Overview
The study tests if personalized dosing of voriconazole, guided by genetic testing and special software, can better control fungal infections in blood cancer patients compared to standard care. It's a randomized trial where participants are split into groups by chance.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Voriconazole dosing will be initiated using current standard care dosing. Samples for TDM and genotype testing will be collected. Based on the results of these tests on Day 5, 8, 14, and up to day 30 ( ± 1 day) patients will be evaluated for dose adjustment using dosing software that includes patient data including TDM and genotype data.
Current standard of care at trial-site institutions uses weight-based (mg/kg) initial dosing of voriconazole, with dose adjustment based on standard therapeutic drug monitoring (TDM) results of measured voriconazole concentrations and based on clinical judgement.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Queensland
Lead Sponsor
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Collaborator
University of Sydney
Collaborator
Royal Adelaide Hospital
Collaborator
Metro North Hospital and Health Service
Collaborator
Sydney Children's Hospitals Network
Collaborator
Royal Brisbane and Women's Hospital
Collaborator
Pathology Queensland
Collaborator
Western Sydney Local Health District
Collaborator
University of Melbourne
Collaborator
Published Research Related to This Trial
Citations
Predicting Voriconazole Outcome With PK/PD Model
Therapeutic drug monitoring is considered to be an effective tool for the individualized use of voriconazole.
Towards Model-Informed Precision Dosing of Voriconazole
This approach aims to predict, individualize, and thereby optimize dosing and therapy outcomes based on patient characteristics and data from ...
Voriconazole concentrations and outcome of invasive ...
An association between poor outcome and voriconazole concentrations, varying from 0.25 to 2 mg/L, has been observed.
CYP2C19‐Guided Voriconazole Therapy: A Precision ...
The collected data included patient demographics, comorbidities, laboratory results, VRCZ dosage, duration, type of fungal infection, and ...
Software for Dosage Individualization of Voriconazole for ...
We developed software to enable the individualization of voriconazole dosing to attain predefined serum concentration targets. The process of individualized ...
An observational efficacy and safety analysis of the ...
Treatment-related adverse events were reported for 18% (22/119) of patients. This observational study confirms the results of previous clinical trials ...
Meta-analysis of the safety of voriconazole in definitive ...
The primary outcome was the proportion of patients who discontinued antifungal therapy due to adverse events. ... Another secondary outcome is ...
Effect of Therapeutic Drug Monitoring on Safety and Efficacy of ...
Of 108 patients, overall mortality was 11 (20%) in the TDM group and 18 (34%) in the non-TDM group at 6 weeks after the initiation of voriconazole therapy and ...
A Study of the Efficacy and Safety of Voriconazole for ...
Study Details | NCT00647907 | A Study of the Efficacy and Safety of Voriconazole for the Treatment of Fungal Infections | ClinicalTrials.gov.
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