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A Study to Compare Two vs. Three Antibiotic Therapies for Pulmonary Mycobacterium Avium Complex Disease
Rochester, MN
The purpose of this study is to determine whether 2-drug therapy is non-inferior to 3-drug therapy against pulmonary mycobacterium avium complex (MAC) disease, and whether 2-drug therapy is better tolerated than 3-drug therapy.
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A Study to Evaluate Lamprene (Clofazimine) to Treat Non-Tuberculous Mycobacterial (NTM) Infections
Jacksonville, FL
The purpose of this study is to evaluate Lamprene (Clofazimine) to treat non-tuberculous mycobacterial (NTM) infections.
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Study of Epetraborole in Patients With Treatment-refractory MAC Lung Disease
Rochester, MN
The purpose of this study is to assess epetraborole + OBR (Optimized Background Regimen) versus placebo + OBR in patients with treatment-refractory MAC lung disease.
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A Study of Inhaled Molgramostim in Cystic Fibrosis Subjects with Nontuberculous Mycobacterial (NTM) Infection
Rochester, MN
The purpose of this study is to evaluate the effectiveness of inhaled molgramostim, administered open-label, to adult cystic fibrosis subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing antimycobacterial guideline based combination therapy.
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A Study to Evaluate the Effectiveness and Safety of an Amikacin Liposome Inhalation Suspension-based Regimen in Adults with Nontuberculous Mycobacterial Lung Infection
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness of ALIS + azithromycin (AZI) + ethambutol (ETH) compared to the empty liposome control (ELC) + AZI + ETH on patient reported respiratory symptoms at Month 13.
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A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared with Placebo for the Treatment of Participants with Mycobacterium Avium Complex (MAC) Pulmonary Disease
Rochester, MN
The purpose of the study is to evaluate the microbiological response and clinical effectiveness of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD). Additionally, to determine the safety and tolerability of SPR720 in a participants population with NTM- PD 3. Also, the pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in a participant population with NTM-PD.
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A Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection
Jacksonville, FL; Rochester, MN
The purpose of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints.