Suspended

Inhaled Amikacin for Treatment of Intractable Nontuberculous Mycobacterial Lung Disease

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What is being tested

Amikacin

Drug
Who is being recruted

Lung Diseases

+ Respiratory Tract Diseases

Over 20 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2012
See protocol details

Summary

Principal SponsorSamsung Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2012

Actual date on which the first participant was enrolled.

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 TitleInhaled Amikacin for Treatment of Intractable Nontuberculous Mycobacterial Lung Disease
NCT01528930
Principal SponsorSamsung Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesRespiratory Tract Diseases

Criteria

4 inclusion criteria required to participate
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
8 exclusion criteria prevent from participating
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)
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Samsung Medical Center

Seoul, South KoreaOpen Samsung Medical Center in Google Maps
SuspendedOne Study Center