This is a phase IV pragmatic, multicentre, randomised, simple-blind, parallel arm, centre-stratified clinical trial. The main objective is to compare efficiency of voriconazole preemptive genotyping strategy, compared with routine practice.
Primary outcome is serum level of voriconazole on fifth day. Secondary outcome is a combined variable of therapeutic failure and adverse events, associated with voriconazole. A total of 146 patients with risk of undergoing invasive aspergillosis who potentially will receive voriconazole will be recruited, and CYP2C19 will be genotyped. If the patient receives voriconazole finally, he will be randomized (1:1 experimental/control). In the experimental arm patients receive dose according to pharmacogenetic algorithm including CYP2C19 genotype and clinical and demographic information. In the control arm patients receive dose according to clinical practice guidelines. In addition, a Spain national health system (NHS) point-of-view cost-effectiveness evaluation is going to be done. Direct costs calculation of each arm will be done.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
146
The patients who finally receives voriconazole will be randomized to receive the dose according to a pharmacogenetic algorithm including CYP2C19 genotype and clinical and demographic information.
The patients who finally receives voriconazole will be randomized to receive the dose according to clinical practice
La Paz University Hospital
Madrid, Spain
RECRUITINGSerum voriconazole concentration
Serum voriconazole concentration within the therapeutic range, in μg/mL.
Time frame: Day 5 of treatment
Therapeutic failure
% of patients with therapeutic failure. A patient has a therapeutic failure if: 1. In patient with suspected or confirmed invasive aspergillosis: drug change or association, because of bad clinical or radiological evolution of the disease. 2. In patient who receive prophylactic treatment: the necessity of change because of suspected or confirmed invasive fungal disease.
Time frame: Within 3 months
Adverse event
% of patients with a dose-dependent drug adverse event reaction. It will be considered dose-dependent drug adverse reactions: * Visual disturbances (photopsias) * Skin reactions * Neurotoxicity (confusion and visual hallucinations) and * Corrected QT interval (QTc) lengthening
Time frame: Within 3 months
Costs by adverse event
Quantifying economic burden (in euros) associated with management of severe adverse events.
Time frame: Day 90 of treatment
Quality adjusted life years (QALY)
Measure of disease burden, including both the quality and the quantity of life lived.
Time frame: Day 90 of treatment
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