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

NCT04922554 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-07-30

Study results available
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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)

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • Paratek Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Amy Manley · Paratek Pharmaceuticals Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2024-06-17
Completion
2024-07-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04922554 on ClinicalTrials.gov