Clinical Research Details

A Phase 2, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Omadacycline in Adult Subjects with Nontuberculous Mycobacterial (NTM) Pulmonary Disease Caused by Mycobacterium abscessus Complex (MABc)

Study Description

This study is investigating the efficacy, safety, and tolerability, of an antibiotic medication called omadacycline in adult subjects with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex (MABc). Omadacycline is approved by the U.S. Food & Drug Administration (FDA) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections. Subjects will receive either omadacycline or placebo and will remain in the study for 5 months.

Inclusion/Exclusion Criteria

Inclusion criteria: Diagnosed MABc pulmonary disease as per Infectious Diseases Society of America/American Thoracic Society guidelines criteria. Subjects must have: 1. At least 2 of the following NTM-infection symptoms at Screening and Baseline: Chronic cough, coughing up blood (hemoptysis), wheezing, chest pain, frequent throat clearing, phlegm or sputum production, shortness of breath, fatigue, fever, night sweats, poor appetite, and/or weight loss. 2. At least 1 positive pulmonary culture for MABc in the 6 months prior to Screening, and 1 positive culture at Screening 3. Radiographic evidence of MABc infection via computed tomography (CT) scan of the chest within 3 months prior to Screening Exclusion criteria: 1. Has received antibiotic treatment within 6 months prior to Screening for MABc or MAC. 2. Has received systemic or inhaled antibiotic therapy (other than chronic macrolide therapy) within 4 weeks prior to Screening 3. Is experiencing an exacerbation of an infection with a non-Mycobacterium species (eg, Pseudomonas aeruginosa) that the investigator considers clinically relevant 4. Any of the following conditions: Active pulmonary malignancy, Radiologic evidence of cavitary disease, Cystic fibrosis, pulmonary tuberculosis, history of lung transplantation

Open Enrollment

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