A Phase I/IIa Prospective, Randomized, Open-Label Study on the Safety and Efficacy of Nebulized Liposomal Amphotericin for Invasive Pulmonary Aspergillosis

Although nebulized liposomal amphotericin B (NLAB) is being used in invasive pulmonary aspergillosis (IPA) prophylaxis, no clinical trial has shown its efficacy as a therapeutic strategy. NAIFI is the inaugural randomized, controlled clinical trial designed to examine the safety and effectiveness of...

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Autores: Fortún, Jesús, Gómez-García de la Pedrosa, Elia, Martínez-Lorca, Alberto, Paredes, Patricia, Martín-Dávila, Pilar, Gomez-Lopez, Alicia, Buitrago, Maria Jose, López-Jiménez, Javier, Gioia, Francesca, Escudero, Rosa, Alvarez-Alvarez, Maria Elena, Soriano, Cruz, Moreno-García, Javier, San Miguel, Diana, Vicente, Noelia, Moreno, Santiago
Tipo de recurso: artículo
Fecha de publicación:2024
País:España
Institución:Instituto de Salud Carlos III (ISCIII)
Repositorio:Repisalud
Idioma:inglés
OAI Identifier:oai:repisalud.isciii.es:20.500.12105/26574
Acceso en línea:https://hdl.handle.net/20.500.12105/26574
Access Level:acceso abierto
Palabra clave:18F-fluorodeoxyglucose positron emission tomography
Invasive pulmonary aspergillosis
Nebulized liposomal amphotericin B
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spelling A Phase I/IIa Prospective, Randomized, Open-Label Study on the Safety and Efficacy of Nebulized Liposomal Amphotericin for Invasive Pulmonary AspergillosisFortún, JesúsGómez-García de la Pedrosa, EliaMartínez-Lorca, AlbertoParedes, PatriciaMartín-Dávila, PilarGomez-Lopez, AliciaBuitrago, Maria JoseLópez-Jiménez, JavierGioia, FrancescaEscudero, RosaAlvarez-Alvarez, Maria ElenaSoriano, CruzMoreno-García, JavierSan Miguel, DianaVicente, NoeliaMoreno, Santiago18F-fluorodeoxyglucose positron emission tomographyInvasive pulmonary aspergillosisNebulized liposomal amphotericin BAlthough nebulized liposomal amphotericin B (NLAB) is being used in invasive pulmonary aspergillosis (IPA) prophylaxis, no clinical trial has shown its efficacy as a therapeutic strategy. NAIFI is the inaugural randomized, controlled clinical trial designed to examine the safety and effectiveness of NLAB (dosage: 25 mg in 6 mL, three times per week for 6 weeks) against a placebo, in the auxiliary treatment of IPA. Throughout the three-year clinical trial, thirteen patients (six NLAB, seven placebo) were included, with 61% being onco-hematological with less than 100 neutrophils/μL. There were no significant differences noted in their pre- and post-nebulization results of forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), and oxygen saturation between the groups. Neither bronchospasm nor serum amphotericin B levels were reported in any patients given NLAB. 18F-Fluorodeoxyglucose positron emission tomography (FDG-PET-TC) was carried out at the baseline and after 6 weeks. A notable decrease in median SUV (standardized uptake value) was observed in NLAB patients after 6 weeks (-3.6 vs. -0.95, p: 0.039, one tail). Furthermore, a reduction in serum substance galactomannan and beta-D-Glucan was identified within NLAB recipients. NLAB is well tolerated and safe for patients with IPA. Encouraging indirect efficacy data have been derived from image monitoring or biomarkers. However, further studies involving more patients are necessary.Multidisciplinary Digital Publishing Institute (MDPI)Instituto de Salud Carlos IIIMinisterio de Sanidad (España)20252025-03-2620242024-03-0120242024-03-01research articlehttp://purl.org/coar/resource_type/c_2df8fbb1VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/20.500.12105/26574reponame:Repisaludinstname:Instituto de Salud Carlos III (ISCIII)InglésengES PI18 00179open accesshttp://purl.org/coar/access_right/c_abf2Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repisalud.isciii.es:20.500.12105/265742026-06-12T12:43:37Z
dc.title.none.fl_str_mv A Phase I/IIa Prospective, Randomized, Open-Label Study on the Safety and Efficacy of Nebulized Liposomal Amphotericin for Invasive Pulmonary Aspergillosis
title A Phase I/IIa Prospective, Randomized, Open-Label Study on the Safety and Efficacy of Nebulized Liposomal Amphotericin for Invasive Pulmonary Aspergillosis
spellingShingle A Phase I/IIa Prospective, Randomized, Open-Label Study on the Safety and Efficacy of Nebulized Liposomal Amphotericin for Invasive Pulmonary Aspergillosis
Fortún, Jesús
18F-fluorodeoxyglucose positron emission tomography
Invasive pulmonary aspergillosis
Nebulized liposomal amphotericin B
title_short A Phase I/IIa Prospective, Randomized, Open-Label Study on the Safety and Efficacy of Nebulized Liposomal Amphotericin for Invasive Pulmonary Aspergillosis
title_full A Phase I/IIa Prospective, Randomized, Open-Label Study on the Safety and Efficacy of Nebulized Liposomal Amphotericin for Invasive Pulmonary Aspergillosis
title_fullStr A Phase I/IIa Prospective, Randomized, Open-Label Study on the Safety and Efficacy of Nebulized Liposomal Amphotericin for Invasive Pulmonary Aspergillosis
title_full_unstemmed A Phase I/IIa Prospective, Randomized, Open-Label Study on the Safety and Efficacy of Nebulized Liposomal Amphotericin for Invasive Pulmonary Aspergillosis
title_sort A Phase I/IIa Prospective, Randomized, Open-Label Study on the Safety and Efficacy of Nebulized Liposomal Amphotericin for Invasive Pulmonary Aspergillosis
dc.creator.none.fl_str_mv Fortún, Jesús
Gómez-García de la Pedrosa, Elia
Martínez-Lorca, Alberto
Paredes, Patricia
Martín-Dávila, Pilar
Gomez-Lopez, Alicia
Buitrago, Maria Jose
López-Jiménez, Javier
Gioia, Francesca
Escudero, Rosa
Alvarez-Alvarez, Maria Elena
Soriano, Cruz
Moreno-García, Javier
San Miguel, Diana
Vicente, Noelia
Moreno, Santiago
author Fortún, Jesús
author_facet Fortún, Jesús
Gómez-García de la Pedrosa, Elia
Martínez-Lorca, Alberto
Paredes, Patricia
Martín-Dávila, Pilar
Gomez-Lopez, Alicia
Buitrago, Maria Jose
López-Jiménez, Javier
Gioia, Francesca
Escudero, Rosa
Alvarez-Alvarez, Maria Elena
Soriano, Cruz
Moreno-García, Javier
San Miguel, Diana
Vicente, Noelia
Moreno, Santiago
author_role author
author2 Gómez-García de la Pedrosa, Elia
Martínez-Lorca, Alberto
Paredes, Patricia
Martín-Dávila, Pilar
Gomez-Lopez, Alicia
Buitrago, Maria Jose
López-Jiménez, Javier
Gioia, Francesca
Escudero, Rosa
Alvarez-Alvarez, Maria Elena
Soriano, Cruz
Moreno-García, Javier
San Miguel, Diana
Vicente, Noelia
Moreno, Santiago
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Instituto de Salud Carlos III
Ministerio de Sanidad (España)
dc.subject.none.fl_str_mv 18F-fluorodeoxyglucose positron emission tomography
Invasive pulmonary aspergillosis
Nebulized liposomal amphotericin B
topic 18F-fluorodeoxyglucose positron emission tomography
Invasive pulmonary aspergillosis
Nebulized liposomal amphotericin B
description Although nebulized liposomal amphotericin B (NLAB) is being used in invasive pulmonary aspergillosis (IPA) prophylaxis, no clinical trial has shown its efficacy as a therapeutic strategy. NAIFI is the inaugural randomized, controlled clinical trial designed to examine the safety and effectiveness of NLAB (dosage: 25 mg in 6 mL, three times per week for 6 weeks) against a placebo, in the auxiliary treatment of IPA. Throughout the three-year clinical trial, thirteen patients (six NLAB, seven placebo) were included, with 61% being onco-hematological with less than 100 neutrophils/μL. There were no significant differences noted in their pre- and post-nebulization results of forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), and oxygen saturation between the groups. Neither bronchospasm nor serum amphotericin B levels were reported in any patients given NLAB. 18F-Fluorodeoxyglucose positron emission tomography (FDG-PET-TC) was carried out at the baseline and after 6 weeks. A notable decrease in median SUV (standardized uptake value) was observed in NLAB patients after 6 weeks (-3.6 vs. -0.95, p: 0.039, one tail). Furthermore, a reduction in serum substance galactomannan and beta-D-Glucan was identified within NLAB recipients. NLAB is well tolerated and safe for patients with IPA. Encouraging indirect efficacy data have been derived from image monitoring or biomarkers. However, further studies involving more patients are necessary.
publishDate 2024
dc.date.none.fl_str_mv 2024
2024-03-01
2024
2024-03-01
2025
2025-03-26
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.12105/26574
url https://hdl.handle.net/20.500.12105/26574
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.relation.none.fl_str_mv ES PI18 00179
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Multidisciplinary Digital Publishing Institute (MDPI)
publisher.none.fl_str_mv Multidisciplinary Digital Publishing Institute (MDPI)
dc.source.none.fl_str_mv reponame:Repisalud
instname:Instituto de Salud Carlos III (ISCIII)
instname_str Instituto de Salud Carlos III (ISCIII)
reponame_str Repisalud
collection Repisalud
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.811543

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