Effectiveness and Efficiency of a Voriconazole Preemptive Genotyping Strategy (VORIGENPHARM)
Invasive Fungal Infections
About this trial
This is an interventional treatment trial for Invasive Fungal Infections
Eligibility Criteria
Inclusion Criteria:
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.
- Those who agree to participate in the study by signing informed consent (patients equal or over 18 years old)
- Subjects under 18 years old whose representative / legal guardian has voluntarily signed the informed consent.
- 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:
- Patients who for any reason should not be included in the study according to the criteria of the research team.
- Subjects who are not capable to understand the information sheet and unable to sign the informed consent.
Sites / Locations
- La Paz University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Experimental group
Control group
Based on the genetic study carried out and the patient's characteristics (age, weight, indication), the Pharmacogenetics Unit of the University Hospital La Paz will indicate the dose to be administered based on the therapeutic individualization protocol guided by pharmacogenetics.
No information will be provided and procedure will be carried out according to normal clinical practice, with clinical monitoring by the doctor in charge.