دورية أكاديمية
Open-Label Trial of Amikacin Liposome Inhalation Suspension in Mycobacterium abscessus Lung Disease.
| العنوان: | Open-Label Trial of Amikacin Liposome Inhalation Suspension in Mycobacterium abscessus Lung Disease. |
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| المؤلفون: | Siegel SAR; Oregon Health & Science University, Portland, OR. Electronic address: siegels@ohsu.edu., Griffith DE; The University of Texas Health Science Center at Tyler, Tyler, TX., Philley JV; The University of Texas Health Science Center at Tyler, Tyler, TX., Brown-Elliott BA; The University of Texas Health Science Center at Tyler, Tyler, TX., Brunton AE; Oregon Health & Science University, Portland, OR., Sullivan PE; Oregon Health & Science University, Portland, OR., Fuss C; Oregon Health & Science University, Portland, OR., Strnad L; Oregon Health & Science University, Portland, OR., Wallace RJ Jr; The University of Texas Health Science Center at Tyler, Tyler, TX., Winthrop KL; Oregon Health & Science University, Portland, OR. |
| المصدر: | Chest [Chest] 2023 Oct; Vol. 164 (4), pp. 846-859. Date of Electronic Publication: 2023 Jun 17. |
| نوع المنشور: | Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 0231335 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1931-3543 (Electronic) Linking ISSN: 00123692 NLM ISO Abbreviation: Chest Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2016- : New York : Elsevier Original Publication: Chicago : American College of Chest Physicians |
| مواضيع طبية MeSH: | Mycobacterium abscessus* , Cystic Fibrosis*/drug therapy , Mycobacterium Infections, Nontuberculous*/drug therapy , Mycobacterium Infections, Nontuberculous*/microbiology, Humans ; Female ; Middle Aged ; Male ; Amikacin ; Anti-Bacterial Agents ; Liposomes/therapeutic use ; Clofazimine/therapeutic use ; Azithromycin/therapeutic use ; Macrolides/therapeutic use ; Drug Resistance, Bacterial ; Leprostatic Agents/therapeutic use ; Microbial Sensitivity Tests |
| مستخلص: | Background: Mycobacterium abscessus is the second most common nontuberculous mycobacterium respiratory pathogen and shows in vitro resistance to nearly all oral antimicrobials. M abscessus treatment success is low in the presence of macrolide resistance. Research Question: Does treatment with amikacin liposome inhalation suspension (ALIS) improve culture conversion in patients with M abscessus pulmonary disease who are treatment naive or who have treatment-refractory disease? Study Design and Methods: In an open-label protocol, patients were given ALIS (590 mg) added to background multidrug therapy for 12 months. The primary outcome was sputum culture conversion defined as three consecutive monthly sputum cultures showing negative results. The secondary end point included development of amikacin resistance. Results: Of 33 patients (36 isolates) who started ALIS with a mean age of 64 years (range, 14-81 years), 24 patients (73%) were female, 10 patients (30%) had cystic fibrosis, and nine patients (27%) had cavitary disease. Three patients (9%) could not be evaluated for the microbiologic end point because of early withdrawal. All pretreatment isolates were amikacin susceptible and only six isolates (17%) were macrolide susceptible. Eleven patients (33%) were given parenteral antibiotics. Twelve patients (40%) received clofazimine with or without azithromycin as companion therapy. Fifteen patients (50%) with evaluable longitudinal microbiologic data demonstrated culture conversion, and 10 patients (67%) sustained conversion through month 12. Six of the 33 patients (18%) demonstrated mutational amikacin resistance. All were patients using clofazimine or clofazimine plus azithromycin as companion medication(s). Few serious adverse events occurred for ALIS users; however, reduction of dosing to three times weekly was common (52%). Interpretation: In a cohort of patients primarily with macrolide-resistant M abscessus, one-half of the patients using ALIS showed sputum culture conversion to negative findings. The emergence of mutational amikacin resistance was not uncommon and occurred with the use of clofazimine monotherapy. Trial Registry: ClinicalTrials.gov; No.: NCT03038178; URL: www. Clinicaltrials: gov. Competing Interests: Financial/Nonfinancial Disclosures The authors have reported to CHEST the following: D. E. G. received support as a consultant from Insmed, Inc., AN2 Therapeutics, and Paratek Pharmaceuticals and received research support from Insmed, Inc. J. V. P. received support as part of advisory boards for Insmed, Inc., AN2 Therapeutics, and Paratek Pharmaceuticals and received research support from Insmed, Inc., AN2 Therapeutics, Paratek Pharmaceuticals, Electromed, Inc., Hillrom, and Zambon. R. J. W. received research support from Insmed, Inc. K. L. W. received support as a consultant from Insmed, Inc., AN2 Therapeutics, Paratek Pharmaceuticals, RedHill Biopharma, Renovion, Inc., and Spero Therapeutics and received research support from Insmed, Inc., AN2 Therapeutics, Paratek Pharmaceuticals, RedHill Biopharma, and Renovion, Inc. None declared (S. A. R. S., B. A. B.-E., A. E. B., P. E. S., C. F., L. S.). (Copyright © 2023 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.) |
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| معلومات مُعتمدة: | UL1 TR002369 United States TR NCATS NIH HHS |
| فهرسة مساهمة: | Keywords: Mycobacterium abscessus; amikacin liposome inhalation suspension; nontuberculous mycobacteria lung disease |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03038178 |
| المشرفين على المادة: | 84319SGC3C (Amikacin) 0 (Anti-Bacterial Agents) 0 (Liposomes) D959AE5USF (Clofazimine) 83905-01-5 (Azithromycin) 0 (Macrolides) 0 (Leprostatic Agents) |
| تواريخ الأحداث: | Date Created: 20230707 Date Completed: 20231009 Latest Revision: 20231119 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC10645596 |
| DOI: | 10.1016/j.chest.2023.05.036 |
| PMID: | 37419144 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1931-3543 |
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| DOI: | 10.1016/j.chest.2023.05.036 |