Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease
Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Non-tuberculous Mycobacterial Lung Disease
Intervention: Amikacin (Drug)
Phase: Phase 2
Status: Withdrawn
Sponsored by: Samsung Medical Center Official(s) and/or principal investigator(s): Won-Jung Koh, Principal Investigator, Affiliation: Samsung Medical Center
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.
Clinical Details
Official title: Inhaled Amikacin for Treatment of Intractable Nontuberculous Mycobacterial Lung Disease
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Culture conversion rates at 6 months
Secondary outcome: Culture conversion rates at 12 monthsCulture conversion rates at 24 months Assessment of abnormal lab values Assessment of adverse events related to the study drug or study device
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Samsung Medical Center, Seoul 135-710, Korea, Republic of
Additional Information
Starting date: February 2012
Last updated: December 14, 2012
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