Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

Inhaled Amikacin for Treatment of Intractable Nontuberculous Mycobacterial Lung Disease

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.

Study Overview

• Status: Withdrawn
• Conditions: Pulmonary Non-tuberculous Mycobacterial Lung Disease
• Intervention / Treatment: Drug: Amikacin

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Amikacin; 500 mg, once daily for 2 years

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Won-Jung Koh, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: January 30, 2012
• First Submitted That Met QC Criteria: February 5, 2012
• First Posted (Estimate): February 8, 2012

Study Record Updates

• Last Update Posted (Estimate): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 14, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Anti-Infective Agents; Lung Diseases; Amikacin; Therapeutic Uses
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Anti-Infective Agents; Anti-Bacterial Agents; Amikacin
• Other Study ID Numbers: 2011-10-104-001