ArticleChest2023
Open-Label Trial of Amikacin Liposome Inhalation Suspension in Mycobacterium abscessus Lung Disease.
Article in Chest, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03038178 (An Open-label Study of Efficacy, Safety and Tolerability of Liposomal Amikacin for Inhalation), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-label Study of Efficacy, Safety and Tolerability of Liposomal Amikacin for Inhalation (LAI) Once Daily in Addition to Standard Multi-antibiotic Therapy in the Treatment of Mycobacterium Abscessus Lung Disease
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.
- Antibiotic treatment for non-tuberculous mycobacteria lung infection in people with cystic fibrosis.The Cochrane database of systematic reviews · 2025Pooled it
- Omadacycline Monotherapy in Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium abscessus: Results From a Phase 2, Double-blind, Randomized, Placebo-controlled Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Trial
- Eravacycline forMicrobiology spectrum · 2026Article
- Liposome-Encapsulated Antibiotics for the Therapy of Mycobacterial Infections.Antibiotics (Basel, Switzerland) · 2025Review
- Effects of Amikacin Liposome Inhalation Suspension and Amikacin Resistance Development in Patients With RefractoryOpen forum infectious diseases · 2025Article
- Liposome-Based Nanoparticle Delivery Systems for Lung Diseases: Opportunities and Challenges.International journal of nanomedicine · 2025Review
- The Advance and Clinical Practice on Lung Disease Caused byInfection and drug resistance · 2025Article
- Toward better cures forClinical microbiology reviews · 2024Review
- Growing from common ground: nontuberculous mycobacteria and bronchiectasis.European respiratory review : an official journal of the European Respiratory Society · 2024Review
- Treatment for non-tuberculous mycobacteria: challenges and prospects.Frontiers in microbiology · 2024Review
- Drug-drug interactions in the management of non-tuberculous mycobacterial infections.Frontiers in microbiology · 2024Review
- The Use of Amikacin Liposome Inhalation Suspension (Arikayce) in the Treatment of Refractory Nontuberculous Mycobacterial Lung Disease in Adults.Drug design, development and therapy · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundMycobacterium 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
methodsIn 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.
resultsOf 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%).
interpretationIn 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.