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Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Non-tuberculous Mycobacterial Lung Disease

Intervention: Amikacin (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Samsung Medical Center

Official(s) and/or principal investigator(s):
Won-Jung Koh, Principal Investigator, Affiliation: Samsung Medical Center


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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Culture conversion rates at 6 months

Secondary outcome:

Culture conversion rates at 12 months

Culture conversion rates at 24 months

Assessment of abnormal lab values

Assessment of adverse events related to the study drug or study device


Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: 1. Diagnosis of NTM lung lung disease in accordance with the 2007 ATS/IDSA criteria. 2. MAC lung disease with persistent sputum culture positive after 6 months of standard treatment 3. M. abscessus lung disease with persistent sputum culture positive after 6 months of standard treatment 4. New case of M. abscessus pulmonary disease after completion of initial 4 weeks intravenous antibiotics treatment Exclusion Criteria: 1. Subjects with negative sputum culture before starting of this study 2. Forced expiratory volume in 1 second (FEV1) <30% of predicted at screening. 3. Positive in HIV test. 4. Subjects with chronic renal insufficient state (serum creatinine level is more than 2. 0 mg/dL) 5. Subjects with decreased liver function (serum total bilirubin level is more than 2 mg/dL or AST or ALT are more than 1. 5 times of upper normal limits) 6. Active any malignancy requiring chemotherapy or radiation therapy within one year prior to screening. 7. Subjects with history of allergy to amikacin. 8. Subjects with pregnant state or women of childbearing age with no appropriate contraception.

Locations and Contacts

Samsung Medical Center, Seoul 135-710, Korea, Republic of
Additional Information

Starting date: February 2012
Last updated: December 14, 2012

Page last updated: August 20, 2015

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