Search

Your search keyword '"Ignacio Darnaude Ximénez"' showing total 4 results
Start Over Author "Ignacio Darnaude Ximénez"
4 results on '"Ignacio Darnaude Ximénez"'

1. Bronchopulmonary Penetration of Isavuconazole in Pulmonary Transplant Recipients (PBISA01): Protocol for a Phase IV Clinical Trial With a Single Treatment Arm

Author

Ignacio Darnaude-Ximénez, Antonio F Caballero-Bermejo, Belén Ruiz-Antorán, Myriam Aguilar-Pérez, Alicia Gómez-López, Aranzazu Sancho-López, Cristian García-Fadul, Elena Diago-Sempere, Manuel Valle Falcones, Piedad Ussetti-Gil, and Cristina Avendaño-Solá

Subjects
Medicine, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

BackgroundAspergillosis is the most frequently observed invasive fungal disease (IFD) in lung transplant recipients. Isavuconazole (ISA) has shown a better safety profile and noninferiority to voriconazole in the treatment of patients with IFD. ObjectiveThe aim of this study is to describe the bronchopulmonary pharmacokinetic profile of oral ISA by analyzing the degree of penetration in the epithelial lining fluid and alveolar macrophages in patients receiving lung transplantation with a diagnosis of IFD. MethodsA total of 12 patients aged ≥18 years receiving a lung transplant with an IFD diagnosis and indication for ISA treatment and follow-up bronchoscopy will be included in the study. After 5 days of treatment with ISA and before the treatment is discontinued, the patients will be randomized (1:1:1:1) to perform the scheduled bronchoscopy at various times after the administration of ISA (2, 4, 8, and 12 hours). In total, 4 blood samples will be obtained per patient: at 72 hours after treatment initiation, on the day of the bronchoscopy, at the time of the bronchoalveolar lavage (simultaneously), and at 7 days after treatment initiation, to analyze tacrolimus and ISA plasma levels. ISA concentrations will be measured in plasma, epithelial lining fluid, and alveolar macrophages by a high-performance liquid chromatography/UV coupled to fluorescence method. ResultsEnrollment for the PBISA01 trial began in October 2020 and was completed in October 2021. All samples will be analyzed once recruitment is complete, and the results are expected to be published in October 2022. ConclusionsThere are no clinical studies that analyze the bronchopulmonary penetration of ISA. Bronchoalveolar lavage performed routinely in the follow-up of lung transplant recipients constitutes an opportunity to analyze the bronchopulmonary penetration of ISA. Trial RegistrationEuropean Clinical Trials Register 2019-004240-30; www.clinicaltrialsregister.eu/ctr-search/trial/2019-004240-30/ES International Registered Report Identifier (IRRID)DERR1-10.2196/37275

Published
2022
Full Text
View/download PDF

2. Pericarditis after administration of the BNT162b2 mRNA COVID-19 vaccine

Author

Almudena Ramírez-García, Alberto Gil Cacho, Sara Lozano Jiménez, Ignacio Darnaude Ximénez, Ramón Aguado-Noya, and Javier Segovia Cubero

Subjects
2019-20 coronavirus outbreak, Messenger RNA, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), MEDLINE, General Medicine, medicine.disease, Virology, Pericarditis, Medicine, business, Scientific Letter, Administration (government)
Published
2021

4. Phase IV clinical trial with a single treatment arm to evaluate bronchopulmonary penetration of isavuconazole in pulmonary transplant recipients (PBISA01): Study protocol clinical trial. (Preprint)

Author

Ignacio Darnaude-Ximénez, Antonio F Caballero-Bermejo, Belén Ruiz-Antorán, Myriam Aguilar-Pérez, Alicia Gómez-López, Aranzazu Sancho-López, Cristian García-Fadul, Elena Diago-Sempere, Manuel Valle-Falconés, Piedad Ussetti-Gil, and Cristina Avendaño-Solá

Abstract

BACKGROUND Aspergillosis is the most frequently observed invasive fungal disease (IFD) in lung transplant recipients. Isavuconazole has shown a better safety profile and non-inferiority to voriconazole in the treatment of patients with IFD. OBJECTIVE The aim of this study is to describe the bronchopulmonary pharmacokinetic profile of oral isavuconazole by analyzing the degree of penetration in the epithelial lining fluid and the alveolar macrophages in patients receiving lung transplantation with a diagnosis of invasive fungal disease. METHODS A total of 12 patients over 18 years of age, lung transplant recipients with IFD diagnosis and indication for isavuconazole treatment and follow-up bronchoscopy will be included in the study. After 5 days of treatment with isavuconazole and before the treatment is discontinued, patients will be randomized to perform the scheduled bronchoscopy at different times from the administration of Isavuconazole (2, 4, 8, 12 hours). Four blood samples will be obtained per patient: at 72 h after treatment initiation, the day of the bronchoscopy, at the time of the BAL (simultaneously) and 7 days after treatment initiation, in order to analyse tacrolimus and isavuconazole plasma levels. Isavuconazole concentrations will be measured in plasma, epithelial lining fluid (ELF) and alveolar macrophages (CA) by a high-performance liquid chromatography/UV couple to Fluorescence method. RESULTS Recruitment is ongoing. No preliminary data have been yet obtained. CONCLUSIONS There are no clinical studies that analyze the bronchopulmonary penetration of isavuconazole. Bronchoalveolar lavage (BAL) performed routinely in the follow-up of lung transplant recipients, constitutes an opportunity to analyze the bronchopulmonary penetration of isavuconazole. CLINICALTRIAL This clinical trial has been registered on the European Clinical Trials Register (www.clinicaltrialsregister.eu), and the registration number is 2019-004240-30.

Published
2022

Catalog

Books, media, physical & digital resources
See catalog results