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)

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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)

Brief description of study

This is a randomized, double-blind, placebo-controlled, active comparator study in eligible subjects with a new diagnosis (initial or subsequent) of MAC lung infection who have not started treatment. Subjects will be randomized at Baseline in a 1:1 ratio to receive one of the 2 treatment regimens: ALIS + AZI + ETH or ELC + AZI + ETH for 12 months.

Clinical Study Identifier: s20-01186

ClinicalTrials.gov Identifier: NCT04677569

Principal Investigator: Doreen J Addrizzo-Harris.

Other Investigator: Rany Condos.

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Brief description of study

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212-263-4432

646-754-7432