Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

This study has been withdrawn prior to enrollment.
(Although this study was approved at the Institutional Review Board, Korea Food & Drug Administration (KFDA) did not approve this study due to safety concern.)
Sponsor:
Information provided by (Responsible Party):
Won-Jung Koh, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01528930
First received: January 30, 2012
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Pulmonary Non-tuberculous Mycobacterial Lung Disease
Drug: Amikacin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Inhaled Amikacin for Treatment of Intractable Nontuberculous Mycobacterial Lung Disease

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Culture conversion rates at 6 months [ Time Frame: 6 months after starting treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Culture conversion rates at 12 months [ Time Frame: 12 months after starting treatment ] [ Designated as safety issue: No ]
  • Culture conversion rates at 24 months [ Time Frame: 24 months after starting treatment ] [ Designated as safety issue: No ]
  • Assessment of abnormal lab values [ Time Frame: For 24 months of treatment ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events related to the study drug or study device [ Time Frame: For 24 months of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: February 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528930

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Won-Jung Koh Samsung Medical Center
  More Information

No publications provided

Responsible Party: Won-Jung Koh, Principal Investigator, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01528930     History of Changes
Other Study ID Numbers: 2011-10-104-001
Study First Received: January 30, 2012
Last Updated: December 14, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Lung Diseases
Anti-Infective Agents
Therapeutic Uses
Amikacin

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Amikacin
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014