Clinical Trial: Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Inhaled Amikacin for Treatment of Intractable Nontuberculous Mycobacterial Lung Disease

Brief 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.


Detailed Summary:
Sponsor: Samsung Medical Center

Current Primary Outcome: Culture conversion rates at 6 months [ Time Frame: 6 months after starting treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Samsung Medical Center

Dates:
Date Received: January 30, 2012
Date Started: February 2012
Date Completion: April 2016
Last Updated: December 14, 2012
Last Verified: December 2012