Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

NCT01528930 | Withdrawn Phase 2

• 1 other identifier: 2011-10-104-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Non-tuberculous Mycobacterial Lung Disease

Keywords

Lung Diseases; Anti-Infective Agents; Therapeutic Uses; Amikacin

Outcome Measures

Primary Outcomes (1)

• Culture conversion rates at 6 months

  6 months after starting treatment

Secondary Outcomes (4)

• 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

Study Arms (1)

Amikacin for inhalation

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.

Drug: Amikacin

Interventions

Amikacin DRUG

500 mg, once daily for 2 years

Amikacin for inhalation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)
• Active any malignancy requiring chemotherapy or radiation therapy within one year prior to screening.
• Subjects with history of allergy to amikacin.
• Subjects with pregnant state or women of childbearing age with no appropriate contraception.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Amikacin

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Won-Jung Koh

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 8, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

KR (1)