Bronchopulmonary Penetration of Isavuconazole in Pulmonary Transplant Recipients (PBISA01) : Protocol for a Phase IV Clinical Trial With a Single Treatment Arm
©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, Cristina Avendaño-Solá, PBISA01-Study Group. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 14.09.2022..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:11 |
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| Enthalten in: |
JMIR research protocols - 11(2022), 9 vom: 14. Sept., Seite e37275 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Darnaude-Ximénez, Ignacio [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Revised 16.12.2022 published: Electronic Citation Status PubMed-not-MEDLINE |
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| doi: |
10.2196/37275 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM346200466 |
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| 245 | 1 | 0 | |a Bronchopulmonary Penetration of Isavuconazole in Pulmonary Transplant Recipients (PBISA01) |b Protocol for a Phase IV Clinical Trial With a Single Treatment Arm |
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| 500 | |a Date Revised 16.12.2022 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a ©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, Cristina Avendaño-Solá, PBISA01-Study Group. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 14.09.2022. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION: European Clinical Trials Register 2019-004240-30; www.clinicaltrialsregister.eu/ctr-search/trial/2019-004240-30/ES | ||
| 520 | |a INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37275 | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a drug efficacy | |
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| 650 | 4 | |a fungal | |
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| 700 | 1 | |a Caballero-Bermejo, Antonio F |e verfasserin |4 aut | |
| 700 | 1 | |a Ruiz-Antorán, Belén |e verfasserin |4 aut | |
| 700 | 1 | |a Aguilar-Pérez, Myriam |e verfasserin |4 aut | |
| 700 | 1 | |a Gómez-López, Alicia |e verfasserin |4 aut | |
| 700 | 1 | |a Sancho-López, Aranzazu |e verfasserin |4 aut | |
| 700 | 1 | |a García-Fadul, Cristian |e verfasserin |4 aut | |
| 700 | 1 | |a Diago-Sempere, Elena |e verfasserin |4 aut | |
| 700 | 1 | |a Valle Falcones, Manuel |e verfasserin |4 aut | |
| 700 | 1 | |a Ussetti-Gil, Piedad |e verfasserin |4 aut | |
| 700 | 1 | |a Avendaño-Solá, Cristina |e verfasserin |4 aut | |
| 700 | 0 | |a PBISA01-Study Group |e verfasserin |4 aut | |
| 700 | 1 | |a García-Gallo, Cristina López |e investigator |4 oth | |
| 700 | 1 | |a Nuevo, Gemma Díaz |e investigator |4 oth | |
| 700 | 1 | |a Hernández, Rosalía Laporta |e investigator |4 oth | |
| 700 | 1 | |a de la Fuente, Maite Lázaro-Carrasco |e investigator |4 oth | |
| 700 | 1 | |a Merino, Teresa |e investigator |4 oth | |
| 700 | 1 | |a Armentia, Cristina |e investigator |4 oth | |
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