CLINICAL TRIAL TO ANALYZE THE BRONCHOPULMONARY PENETRANCE OF ISAVUCONAZOLE IN PULMONARY TRANSPLANT RECIPIENTS PATIENTS

Phase 1

• Conditions: ung transplant recipients with a diagnosis of invasive fungal disease; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-004240-30-ES
• Lead Sponsor: FUNDACIÓN PARA LA INVESTIGACION BIOMEDICA HU PUERTA DE HIERRO MAJADAHONDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-02
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

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