Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

Summary

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.

Timeline

Start

2012-02

Primary completion

2015-12

Completion

2016-04

Outcome

Outcome not reported

Stopped: “Although this study was approved at the Institutional Review Board, Korea Food \& Drug Administration (KFDA) did not approve this study due to safety concern.”

Drugs

Indications