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- (INS-416) ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
Clinical Trial
(INS-416) ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
This study is for adults who have a certain kind of lung infection. This lung infection is called nontuberculous mycobacterial (NTM) lung infection. The purpose is to see if a new treatment is safe and effective for this kind of lung infection.
Eligibility Criteria
- Inclusion Criteria: *Male or female 18 years of age and older *Current diagnosis of MAC lung infection (by recent positive sputum culture). *Recent CT scan or chest (CT) scan with contrast Exclusion Criteria: *Diagnosis of cystic fibrosis (CF) *History of 3 or more prior MAC lung infections *Relapse of prior MAC lung infection
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