EUCTR2019-000376-41-ES
Active, not recruiting
Phase 1
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 sites146 target enrollmentApril 12, 2019
ConditionsInvasive fungal disease in the hematologic patient.MedDRA version: 20.0 Level: HLGT Classification code 10017528 Term: Fungal infectious disorders System Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0 Level: HLT Classification code 10040054 Term: Sepsis, bacteraemia, viraemia and fungaemia NEC System Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0 Level: HLT Classification code 10029355 Term: Neutropenias System Organ Class: 100000004851MedDRA version: 20.0 Level: LLT Classification code 10076734 Term: Chemotherapy induced neutropenia System Organ Class: 100000004851MedDRA version: 20.1 Level: PT Classification code 10061187 Term: Haematopoietic neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10059041 Term: Allogeneic peripheral haematopoietic stem cell transplant System Organ Class: 100000004865MedDRA version: 20.0 Level: LLT Classification code 10059040 Term: Autologous peripheral haematopoietic stem cell transplant System Organ Class: 100000004865Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]
DrugsVoriconazol
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Invasive fungal disease in the hematologic patient.
- Sponsor
- Fundación de Investigación del Hospital Universitario La Paz (FIBHULP)
- Enrollment
- 146
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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.
Outcomes
Primary Outcomes
Not specified
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