Randomized and multicenter clinical trial to evaluate the effectiveness and efficiency of a voriconazole preemptive genotyping strategy in patients with risk of aspergillosis.

Fundación de Investigación del Hospital Universitario La Paz (FIBHULP)0 个研究点目标入组 146 人开始时间: 2019年4月12日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1. Patient at risk of developing invasive aspergillosis, potential receipent of 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 yeras 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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 73
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 37
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 36

•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.

发起方

Fundación de Investigación del Hospital Universitario La Paz (FIBHULP)