This is a pivotal Phase 2/3, double-blind, placebo-controlled study of oral study drug epetraborole + OBR (Optimized background regimen) versus placebo + OBR in patients with treatment-refractory MAC lung disease. A total of approximately 314 patients will be enrolled in this Phase 2/3 study. For the Phase 2 and Phase 3 parts of the study, the duration of study participation for each patient, not including
Screening, will be up to approximately 19 months. During the conduct of the study, an independent Data and Safety Monitoring Board (DSMB) will be responsible for periodic review of unblinded study safety data by performing a qualitative and quantitative safety assessment.

This is a prospective, multicenter open-label study in adults with CF who are colonized with NTM. Subjects will receive two 5-day infusion cycles of IV gallium. The study will evaluate the safety and antimycobacterial effect of two 5-day infusions of IV gallium. Subjects will be on study for up to 148 days, with a screening period of up to 7 days and active study period up to 20 days. About 40 people with CF who are 18 years of age or older will take part in this study at about 10 hospitals and clinics around the country.

The purpose of this study is to learn more about the safety and effectiveness of the drug omadacyline for people with Nontuberculous Mycobacterial (NTM) pulmonary disease, caused by a type of mycobacteria called Mycobacterium abscessus complex (MABc). Participants will be randomly assigned to receive either omadacycline or placebo, with a 60% chance of being treated with omadacycline and a 40% chance of being treated with placebo. About 75 men and women with NTM lung infection caused by MABc, ages 18 and up, will be in this study, with an estimated 4 participants being enrolled from the MUSC site. Participants will be in this study for approximately 5 months in total, beginning with the Screening visit and continuing until their last study visit.

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. Around 250 subjects 18 years and older with newly diagnosed NTM lung infection caused by MAC who have not started standard treatment are expected to participate in this study. The study will last around 17.5 months from the Screening visit to the end of the study.

The purpose of this study is to better understand treatment practices for Mycobacterium avium complex (MAC) disease. This study is comparing the effectiveness and tolerability of taking 2 drugs compared to 3 drugs in people with MAC disease.

The goal of this cohort and biorepository is to collect data and blood specimens on individuals with Nontuberculous Mycobacteria (NTM), pulmonary disease, and healthy adults to better understand the illness and ultimately improve the care and survival of those with these conditions.

Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM).

If you have been diagnosed with NTM, then your doctor may decide that this infection can be treated with Lamprene®/Clofazimine. This medicine is provided to you in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because you have a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because you have had side effects that prevent the use of other drugs.