The incidence of chronic pulmonary disease caused by nontuberculous mycobacteria (NTM) in human immunodeficiency virus (HIV)-negative patients has been increasing worldwide. In Korea, the common etiologic pathogens for this disease are Mycobacterium avium complex (MAC) and Mycobacterium abscessus. Treating NTM lung diseases can be extremely difficult and may require multiple drugs. Amikacin is an effective antibiotic for NTM infection. However, intravenous amikacin treatment is limited by its systemic route of administration and a lot of adverse events. Amikacin inhalation treatment could overcome these limitations and also could be effective for treatment of NTM pulmonary disease due to maintaining a high lung concentration. The purpose of this study is to determine whether amikacin inhalation treatment is effective in patients with MAC infection who experienced treatment failure after standard treatment for more than 6 months or with M. abscessus infection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
500 mg, once daily for 2 years
Samsung Medical Center
Seoul, South Korea
Culture conversion rates at 6 months
Time frame: 6 months after starting treatment
Culture conversion rates at 12 months
Time frame: 12 months after starting treatment
Culture conversion rates at 24 months
Time frame: 24 months after starting treatment
Assessment of abnormal lab values
Time frame: For 24 months of treatment
Assessment of adverse events related to the study drug or study device
Time frame: For 24 months of treatment
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