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

Autor: Fortún J; Department of Infectious Diseases, Hospital Universitario 'Ramon y Cajal', Avda Colmenar Km 9,1, 28034 Madrid, Spain.; Instituto de Investigación Sanitaria Hospital 'Ramón y Cajal' (IRYCIS), 28034 Madrid, Spain.; Department of Medicine, Universidad Alcalá, 28801 Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de 5 Salud Carlos III, 28029 Madrid, Spain., Gómez-García de la Pedrosa E; Instituto de Investigación Sanitaria Hospital 'Ramón y Cajal' (IRYCIS), 28034 Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de 5 Salud Carlos III, 28029 Madrid, Spain.; Department of Microbiology, Hospital Universitario 'Ramon y Cajal', 28034 Madrid, Spain., Martínez-Lorca A; Instituto de Investigación Sanitaria Hospital 'Ramón y Cajal' (IRYCIS), 28034 Madrid, Spain.; Department of Nuclear Medicine, Hospital Universitario 'Ramon y Cajal', 28034 Madrid, Spain., Paredes P; Instituto de Investigación Sanitaria Hospital 'Ramón y Cajal' (IRYCIS), 28034 Madrid, Spain.; Department of Nuclear Medicine, Hospital Universitario 'Ramon y Cajal', 28034 Madrid, Spain., Martín-Dávila P; Department of Infectious Diseases, Hospital Universitario 'Ramon y Cajal', Avda Colmenar Km 9,1, 28034 Madrid, Spain.; Instituto de Investigación Sanitaria Hospital 'Ramón y Cajal' (IRYCIS), 28034 Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de 5 Salud Carlos III, 28029 Madrid, Spain., Gómez-López A; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de 5 Salud Carlos III, 28029 Madrid, Spain.; Mycology Reference and Research Laboratory, Centro Nacional de Microbiología, 28034 Madrid, Spain., Buitrago MJ; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de 5 Salud Carlos III, 28029 Madrid, Spain.; Mycology Reference and Research Laboratory, Centro Nacional de Microbiología, 28034 Madrid, Spain., López-Jiménez J; Instituto de Investigación Sanitaria Hospital 'Ramón y Cajal' (IRYCIS), 28034 Madrid, Spain.; Department of Medicine, Universidad Alcalá, 28801 Madrid, Spain.; Department of Hematology, Hospital Universitario 'Ramon y Cajal', 28034 Madrid, Spain., Gioia F; Department of Infectious Diseases, Hospital Universitario 'Ramon y Cajal', Avda Colmenar Km 9,1, 28034 Madrid, Spain.; Instituto de Investigación Sanitaria Hospital 'Ramón y Cajal' (IRYCIS), 28034 Madrid, Spain., Escudero R; Department of Infectious Diseases, Hospital Universitario 'Ramon y Cajal', Avda Colmenar Km 9,1, 28034 Madrid, Spain.; Instituto de Investigación Sanitaria Hospital 'Ramón y Cajal' (IRYCIS), 28034 Madrid, Spain.; Department of Medicine, Universidad Alcalá, 28801 Madrid, Spain., Alvarez-Alvarez ME; Department of Infectious Diseases, Hospital Universitario 'Ramon y Cajal', Avda Colmenar Km 9,1, 28034 Madrid, Spain.; Instituto de Investigación Sanitaria Hospital 'Ramón y Cajal' (IRYCIS), 28034 Madrid, Spain., Soriano C; Instituto de Investigación Sanitaria Hospital 'Ramón y Cajal' (IRYCIS), 28034 Madrid, Spain.; Intensive Care Unit, Hospital Universitario 'Ramon y Cajal', 28034 Madrid, Spain., Moreno-García J; Department of Infectious Diseases, Hospital Universitario 'Ramon y Cajal', Avda Colmenar Km 9,1, 28034 Madrid, Spain.; Instituto de Investigación Sanitaria Hospital 'Ramón y Cajal' (IRYCIS), 28034 Madrid, Spain., San Miguel D; Instituto de Investigación Sanitaria Hospital 'Ramón y Cajal' (IRYCIS), 28034 Madrid, Spain.; Department of Pneumology, Hospital Universitario 'Ramon y Cajal', 28034 Madrid, Spain., Vicente N; Instituto de Investigación Sanitaria Hospital 'Ramón y Cajal' (IRYCIS), 28034 Madrid, Spain.; Department of Pharmacy, Hospital Universitario 'Ramon y Cajal', 28034 Madrid, Spain., Moreno S; Department of Infectious Diseases, Hospital Universitario 'Ramon y Cajal', Avda Colmenar Km 9,1, 28034 Madrid, Spain.; Instituto de Investigación Sanitaria Hospital 'Ramón y Cajal' (IRYCIS), 28034 Madrid, Spain.; Department of Medicine, Universidad Alcalá, 28801 Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de 5 Salud Carlos III, 28029 Madrid, Spain.
Jazyk: angličtina
Zdroj: Journal of fungi (Basel, Switzerland) [J Fungi (Basel)] 2024 Mar 01; Vol. 10 (3). Date of Electronic Publication: 2024 Mar 01.
DOI: 10.3390/jof10030191
Abstrakt: 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. 18 F-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.
Databáze: MEDLINE
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