Southeastern Research Center | Winston-Salem, NC
Status and phase
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About
The purpose of this study is to evaluate the efficacy, safety and tolerability of oral omadacycline as compared to placebo in the treatment of adults with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex (MABc)
Full description
The total duration of subject participation in the study is approximately 5 months which includes a total duration of study treatment for approximately 3 months (84 days). Eligible participants will be randomized 1.5:1 to receive 3 months of treatment with either omadacycline or placebo (monotherapy). The study will use a double-dummy design in order to maintain the study blinding.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
75 participants in 2 patient groups, including a placebo group
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Central trial contact
Amy Manley; Alissa Sirbu
Data sourced from clinicaltrials.gov
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