NCT04922554

Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Paratek Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Mycobacterium Infections, Nontuberculous
• Mycobacterium Abscessus Infection
• Nontuberculous Mycobacterial Lung Disease
• Nontuberculous Mycobacterial Pulmonary Infection

Interventions

Type	Name	Description
DRUG	Omadacycline Oral Tablet	omadacycline 300 mg orally, once daily (150 mg tablets x 2)
DRUG	Placebo	placebo tablets resembling omadacycline orally, once daily (x 2 tablets)

Timeline

• Start date: 2021-10-15
• Primary completion: 2024-06-17
• Completion: 2024-07-17
• First posted: 2021-06-10
• Last updated: 2025-07-30
• Results posted: 2025-07-30

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study