The CONVERT Study: Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC)
Brief Description Of Study
This study is recruiting patients that have been diagnosed with a nontuberculous mycobacterial (NTM) lung infection that is caused by Mycobacterium avium complex (MAC; also known as MAI) and that have a history of failing to improve on standard treatments. MAC includes bacteria (germs) that are commonly found in the environment and can cause lung infections in predisposed people.
Detailed Study Description
The purpose of the study is to test the efficacy and safety of a medication that has not been approved for use in the treatment of NTM called Liposomal Amikacin for Inhalation (LAI), given once a day using a nebulizer in patients with lung infection due to MAC that has not previously been successfully treated. LAI will be administered in addition to standard therapy with other medications against lung infection called multi-drug therapy. The study is being conducted to learn the effects (good and bad) of the study drug LAI on you and your lung infection, test what the body does to the study drug, LAI and see if LAI improves your quality of life.
Additional Information About The Study
Eligibility Criteria • Be 18 years of age or older • Have an active lung infection caused by a specific group of bacteria (germs) called Mycobacterium avium Complex (MAC) and a history of failing to improve on treatment • Not be pregnant, trying to become pregnant, or nursing a baby. • Not have cystic fibrosis, active tuberculosis, or a history of lung transplant • Be willing to use specific medicine for the duration of the study • Meet all the requirements needed for participation in the study