Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Pulmonary Non-tuberculous Mycobacterial Lung Disease

Intervention / Treatment
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* Drug: Amikacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of NTM lung lung disease in accordance with the 2007 ATS/IDSA criteria. MAC lung disease with persistent sputum culture positive after 6 months of standard treatment M. abscessus lung disease with persistent sputum culture positive after 6 months of standard treatment New case of M. abscessus pulmonary disease after completion of initial 4 weeks intravenous antibiotics treatment Exclusion Criteria: Subjects with negative sputum culture before starting of this study Forced expiratory volume in 1 second (FEV1) <30% of predicted at screening. Positive in HIV test. Subjects with chronic renal insufficient state (serum creatinine level is more than 2.0 mg/dL) 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) Active any malignancy requiring chemotherapy or radiation therapy within one year prior to screening. Subjects with history of allergy to amikacin. Subjects with pregnant state or women of childbearing age with no appropriate contraception.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amikacin for inhalation<br>Drug: Amikacin Amikacin is provided for inhalation via nebulization. 500 mg of amikacin is administered once daily using the Pari-Boy N/Long Life Nebulizer. Administration time is approximately 20 minutes. Amikacin will be administered for 2 years. | Drug: Amikacin<br>* 500 mg, once daily for 2 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Culture conversion rates at 6 months |  | 6 months after starting treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Culture conversion rates at 12 months |  | 12 months after starting treatment | 
| Culture conversion rates at 24 months |  | 24 months after starting treatment | 
| Assessment of abnormal lab values |  | For 24 months of treatment | 
| Assessment of adverse events related to the study drug or study device |  | For 24 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Diseases, Anti-Infective Agents, Therapeutic Uses, Amikacin