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Bronchopulmonary Penetration of Isavuconazole in Pulmonary Transplant Recipients (PBISA01): Protocol for a Phase IV
Ignacio Darnaude-Ximénez1, Antonio F Caballero-Bermejo1, Belén Ruiz-Antorán1
1Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, Madrid, Spain.
Background:
Aspergillosis 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.
Objective:
The 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.
Methods:
A 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.
Results:
Enrollment 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.
Conclusions:
There 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 Registration:
European 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.
Insights
This study investigates the lung penetration of isavuconazole (ISA) in lung transplant patients with invasive fungal disease (IFD). It analyzes ISA concentrations in epithelial lining fluid and alveolar macrophages to understand its effectiveness.
Area of Science:
- Pharmacology
- Transplantation Medicine
- Infectious Diseases
Background:
- Aspergillosis is a common invasive fungal disease (IFD) in lung transplant recipients.
- Isavuconazole (ISA) offers a favorable safety profile and comparable efficacy to voriconazole for IFD treatment.
Purpose of the Study:
- To determine the bronchopulmonary pharmacokinetic profile of oral isavuconazole (ISA).
- To analyze ISA penetration into epithelial lining fluid and alveolar macrophages in lung transplant recipients with IFD.
Main Methods:
- 12 lung transplant patients with IFD received oral ISA.
- Bronchoscopy was performed at 2, 4, 8, or 12 hours post-ISA dose.
- ISA concentrations were measured in plasma, epithelial lining fluid, and alveolar macrophages using HPLC/UV.
Main Results:
- Study enrollment completed in October 2021.
- Results are anticipated for publication in October 2022.
Conclusions:
- No prior clinical studies have assessed the bronchopulmonary penetration of ISA.
- Routine bronchoscopy in lung transplant recipients provides an opportunity to evaluate ISA's lung penetration.
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