Clinical Research Details

A Study to Evaluate an Amikacin Liposome Inhalation Suspension Based Regimen in Adults with Newly Diagnosed NTM Lung Infection Caused by Mycobacterium avium Complex (MAC)

Study Description

The purpose of this study is to evaluate the effect and safety of amikacin liposome inhalation suspension (ALIS) study treatment on patient-reported symptoms in subjects newly diagnosed with NTM lung infection caused by MAC who have not started standard treatment. This is an experimental clinical research study, and ALIS is an experimental drug. The study will last around 17.5 months from the Screening visit to the end of the study.

Inclusion/Exclusion Criteria

Inclusion criteria: 1. Current diagnosis of MAC lung infection AND has not started antibiotic treatment for MAC. MAC or mixed infection with MAC as the dominant species is allowed, with MAC as the intended organism for treatment 2. Positive sputum culture for MAC within 6 months prior to Screening and at Screening

Exclusion criteria: 1. Diagnosis of cystic fibrosis 2. History of more than 3 MAC lung infections 3. Received any mycobacterial antibiotic treatment for current MAC lung infection 4. Refractory MAC lung infection, defined as having positive MAC cultures while being treated with a multidrug mycobacterial antibiotic treatment regimen for a minimum of 6 consecutive months and no documented successful treatment

Open Enrollment

Contact Name: Ashleigh Trapuzzano
Contact Phone: (904) 244-9633
Contact Email: