Clinical Trial to evaluate the effectivity and efficiency of preemptive genotyping before treatment with voriconazole

Phase 1

• Conditions: Invasive 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 infestations; MedDRA version: 20.0 Level: HLT Classification code 10040054 Term: Sepsis, bacteraemia, viraemia and fungaemia NEC System Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0 Level: HLT Classification code 10029355 Term: Neutropenias System Organ Class: 100000004851; MedDRA version: 20.0 Level: LLT Classification code 10076734 Term: Chemotherapy induced neutropenia System Organ Class: 100000004851; MedDRA 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: 100000004865; MedDRA version: 20.0 Level: LLT Classification code 10059040 Term: Autologous peripheral haematopoietic stem cell transplant System Organ Class: 100000004865; Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

• Registration Number: EUCTR2019-000376-41-ES
• Lead Sponsor: Fundación de Investigación del Hospital Universitario La Paz (FIBHULP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 146

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluating the effectiveness and efficiency of a strategy of anticipated genotyping of voriconazole in the treatment and prophylaxis of fungal infections by aspergillus in haematological patients.;<br> Secondary Objective: 1. To evaluate the effectiveness of a strategy of anticipated genotyping of voriconazole to achieve adequate therapeutic levels in haematological patients with risk of fungal infection, in comparison with usual clinical practice.<br> 2. To evaluate the efficacy and safety of anticipated genotyping of voriconazole in haematological patients with risk of fungal infection, in comparison with usual clinical practice.<br> 3. Evaluate the efficiency of this strategy of anticipated genotyping.<br> ;Primary end point(s): Serum voriconazole concentration within the therapeutic range start of treatment.;Timepoint(s) of evaluation of this end point: 5th day after the treatment start.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Not applicable;<br> Secondary end point(s): 1. Therapeutic failure and adverse events. COMBINED VARIABLE THAT INCLUDE:<br> - Change of antifungal or the association with another antifungal agent due to poor clinical-radiological evolution.<br> - Need for antifungal change, due to suspicion or confirmation of invasive fungal disease.<br> 2. Adverse dose-related adverse events associated with treatment with voriconazole: visual disturbances (photopsias), skin reactions, neurotoxicity (confusion and visual hallucinations) and QTc lengthening.<br>