ALIS in Participants with Nontuberculous Mycobacterial Lung Infection caused by Mycobacterium Avium Complex

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 research study is led by: Dr. O'Neil Green

Participation Details:

Active Date: April 21, 2023

Start Date: January 30, 2023

IRB Number: 1882806

Condition/Disease: Pulmonary/ Critical Care, Infection

Location: Baystate Medical Center

Purpose:
The purpose of the clinical trial is to assess a study drug as a potential treatment option for patients newly diagnosed with a MAC lung infection.

Eligibility:

Inclusion

• Current diagnosis of MAC lung infection. MAC or mixed infection with MAC as the dominant species is allowed, with MAC as the intended organism for treatment.

Exclusion

• Diagnosis of cystic fibrosis (CF)
• History of more than 3 MAC lung infections.
• Received any mycobacterial antibiotic treatment for current MAC lung infection.

Time Commitment: 17.5 months

Status: Active

Current Trial Type: Outpatient

Phase: 3b

Contact Name: Dr. O'Neil Green

Phone: 413-794-7330