Pulmonary Non-tuberculous Mycobacterial Lung Disease Clinical Trial
Official title:
Inhaled Amikacin for Treatment of Intractable Nontuberculous Mycobacterial Lung Disease
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment