At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 66 enrolled
Drug / intervention
Omadacycline Oral Tablet +1 moredrug
Likely dose
Omadacycline Oral Tablet 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Ph. 2, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, & Tolerability of Oral Omadacycline in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex
In Brief
A Phase 2 clinical trial evaluating Omadacycline Oral Tablet and Placebo for Mycobacterium Infections, Nontuberculous and 3 related conditions. Completed, enrolled 66 participants across 17 sites.
Detailed Summary
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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection, Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterial Pulmonary Infection
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedJun 2021
Enrollment StartOct 2021
Primary CompletionJun 2024
Study CompletionJul 2024
TodayJul 2026
First PostedJun 10, 2021
Enrollment StartOct 15, 2021
Primary CompletionJun 17, 2024
Study CompletionJul 17, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.1 years ago
Interventions
Omadacycline Oral Tabletdrug
omadacycline 300 mg orally, once daily (150 mg tablets x 2)
Placebodrug
placebo tablets resembling omadacycline orally, once daily (x 2 tablets)