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Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

NCT ID: NCT01528930

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-04-30

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.

Detailed Description

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Conditions

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Pulmonary Non-tuberculous Mycobacterial Lung Disease

Keywords

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Lung Diseases Anti-Infective Agents Therapeutic Uses Amikacin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Amikacin

Intervention Type DRUG

500 mg, once daily for 2 years

Interventions

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Amikacin

500 mg, once daily for 2 years

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Won-Jung Koh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Won-Jung Koh

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2011-10-104-001

Identifier Type: -

Identifier Source: org_study_id