Effectiveness and Efficiency of a Voriconazole Preemptive Genotyping Strategy
Effectiveness and Efficiency of a Voriconazole Preemptive Genotyping Strategy
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.
Inclusion Criteria:

 1. Patient at risk of developing invasive aspergillosis, that will potentially receive
 treatment or prophylaxis with voriconazole:

 A. Pediatric population: children who are going to receive a transplant of
 hematopoietic precursors (HSCT) and acute myeloid leukemias, as well as relapses of
 it.

 B. Adult population: patients diagnosed with acute leukemia, and those patients with
 expected prolonged neutropenia, secondary to hematological process and / or after
 specific treatment (aplastic anemia and variants, myelodysplastic syndrome, solid
 organ or bone marrow transplant, etc.), and those whose responsible clinician consider
 individually that they could present a risk of developing a fungal infection.

 2. Those who agree to participate in the study by signing informed consent (patients
 equal or over 18 years old)

 3. Subjects under 18 years old whose representative / legal guardian has voluntarily
 signed the informed consent.

 4. In the case of mature under 18 years subjects (12-17 years of age), in addition to the
 consent signed by the legal guardian, the consent of the subject will be obtained.

 Exclusion Criteria:

 1. Patients who for any reason should not be included in the study according to the
 criteria of the research team.

 2. Subjects who are not capable to understand the information sheet and unable to sign
 the informed consent.