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Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

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ClinicalTrials.gov Identifier: NCT01528930
Recruitment Status : Withdrawn (Although this study was approved at the Institutional Review Board, Korea Food & Drug Administration (KFDA) did not approve this study due to safety concern.)
First Posted : February 8, 2012
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):
Won-Jung Koh, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE January 30, 2012
First Posted Date  ICMJE February 8, 2012
Last Update Posted Date December 17, 2012
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2012)
Culture conversion rates at 6 months [ Time Frame: 6 months after starting treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01528930 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2012)
  • Culture conversion rates at 12 months [ Time Frame: 12 months after starting treatment ]
  • Culture conversion rates at 24 months [ Time Frame: 24 months after starting treatment ]
  • Assessment of abnormal lab values [ Time Frame: For 24 months of treatment ]
  • Assessment of adverse events related to the study drug or study device [ Time Frame: For 24 months of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease
Official Title  ICMJE Inhaled Amikacin for Treatment of Intractable Nontuberculous Mycobacterial Lung Disease
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Non-tuberculous Mycobacterial Lung Disease
Intervention  ICMJE Drug: Amikacin
500 mg, once daily for 2 years
Study Arms  ICMJE 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.
Intervention: Drug: Amikacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 14, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2012)
64
Estimated Study Completion Date  ICMJE April 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528930
Other Study ID Numbers  ICMJE 2011-10-104-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Won-Jung Koh, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Won-Jung Koh Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP