Pulmonary Non-tuberculous Mycobacterial Lung Disease
Conditions
Keywords
Lung Diseases, Anti-Infective Agents, Therapeutic Uses, Amikacin
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.
Interventions
DRUGAmikacin
500 mg, once daily for 2 years
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Culture conversion rates at 6 months | 6 months after starting treatment |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed