Phase IV, unicentric, multiple dose, clinical trial, with a single treatment arm to evaluate bronchopulmonary penetration of isavuconazole in pulmonary transplant recipients (PBISA01) - PS-ISA-01

FUNDACIÓN PARA LA INVESTIGACION BIOMEDICA HU PUERTA DE HIERRO MAJADAHONDA0 个研究点目标入组 12 人开始时间: 2019年12月2日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•- Receptors of a lung transplant older than 18 years who, with indication of treatment with isavuconazole according to the technical sheet.
•- Will and ability to meet scheduled visits, treatment plan, laboratory analysis and other study procedures.
•- They must be legally competent and able to understand, sign and date the informed consent form.
•- Signing of the written informed consent in accordance with ICH / GCP and local legislation, obtained before any study procedure.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 12
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Allergy or intolerance to isavuconazole.
•- Contraindication for bronchoscopy and / or BAL.
•- Any clinical condition, and / or analytical alteration to participate in the study.
•- Individuals who show inability to follow the instructions or collaborate during the study.
•- Women with positive results of the pregnancy or breastfeeding test.
•- Having participated in another clinical trial during the 3 months prior to the start of the study in which a research drug or a commercially available drug was tested.
•- Lack of will or inability to follow the procedures described in the protocol.
•- Inability to grant written informed consent.

发起方

FUNDACIÓN PARA LA INVESTIGACION BIOMEDICA HU PUERTA DE HIERRO MAJADAHONDA