Clinical trial NCT01528930: Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease
Official title: Inhaled Amikacin for Treatment of Intractable Nontuberculous Mycobacterial Lung Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pulmonary Non-tuberculous Mycobacterial Lung Disease
Keywords: Lung Diseases
Anti-Infective Agents
Therapeutic Uses
Amikacin
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Culture conversion rates at 6 months
timeFrame: 6 months after starting treatment
Secondary outcomes:
measure: Culture conversion rates at 12 months
timeFrame: 12 months after starting treatment
measure: Culture conversion rates at 24 months
timeFrame: 24 months after starting treatment
measure: Assessment of abnormal lab values
timeFrame: For 24 months of treatment
measure: Assessment of adverse events related to the study drug or study device
timeFrame: For 24 months of treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won-Jung Koh
role: PRINCIPAL_INVESTIGATOR
References: