Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

Overview

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.

Full Title of Study: “Inhaled Amikacin for Treatment of Intractable Nontuberculous Mycobacterial Lung Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

Interventions

  • Drug: Amikacin
    • 500 mg, once daily for 2 years

Arms, Groups and Cohorts

  • Experimental: Amikacin for inhalation
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Culture conversion rates at 6 months
    • Time Frame: 6 months after starting treatment

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Samsung Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Won-Jung Koh, Principal Investigator – Samsung Medical Center
  • Overall Official(s)
    • Won-Jung Koh, Principal Investigator, Samsung Medical Center

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