Last-Resort drug made available for stubborn lung infections

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female patients 18 years of age or older 2. Written informed consent must be obtained before any project specific assessment is performed. 3. Patients previously diagnosed with NTM infection with local or disseminated infection(i.e. patients with any NTM species at any site of infection) 4. Patients who failed or are intolerant of prior therapies or who have baseline macrolide resistance or for whom an appropriate regimen cannot otherwise be devised 5. Male patients (including vasectomized patients) who agree to use a condom during intercourse while taking clofazimine treatment and for at least 4 months after stopping treatment with clofazimine 6. Female patients of child-bearing potential with negative pregnancy test before clofazimine treatment initiation and who confirm no intention to become pregnant during the treatment with clofazimine, by using highly effective methods of contraception (methods that result in less than 1% pregnancy rates) while taking clofazimine treatment and for at least 4 months after stopping treatment with clofazimine Exclusion Criteria: 1. History of hypersensitivity to any drugs or metabolites of similar chemical classes as clofazimine 2. History or current diagnosis of clinically significant ECG abnormalities that pose a safety risk for the patient, such as clinically significant cardiac arrhythmias (e.g.,sustained ventricular tachycardia, second or third degree heart block without a pacemaker) 3. History or additional risk factors for Torsades de Pointes such as heart failure, clinically relevant hypokalemia, familial long QT syndrome or known family history of Torsades de Pointes 4. Confirmed demonstration of resting QTcF \>500 msec at screening 5. Any condition (social, psychiatric, or medical) which in the opinion of the treating physician would make participation in this MPP unsafe 6. Unable to swallow capsules 7. HIV-infected patients with disseminated NTM infection 8. Life expectancy less than 6 months 9. Pregnant or nursing (lactating) females