Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
NCT ID: NCT04922554
Last Updated: 2025-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2021-10-15
2024-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Omadacycline 300 mg PO
omadacycline 150 mg tablets (x 2) administered orally, once daily, q24h
Omadacycline Oral Tablet
omadacycline 300 mg orally, once daily (150 mg tablets x 2)
Placebo PO
Placebo tablets resembling omadacycline (x 2) administered once daily, q24h
Placebo
placebo tablets resembling omadacycline orally, once daily (x 2 tablets)
Interventions
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Omadacycline Oral Tablet
omadacycline 300 mg orally, once daily (150 mg tablets x 2)
Placebo
placebo tablets resembling omadacycline orally, once daily (x 2 tablets)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has at least 2 of the following NTM-infection symptoms present 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.
* At least 1 positive pulmonary (sputum) culture for MABc in the 6 months prior to Screening and 1 positive culture at Screening
* Radiographic evidence of MABc infection via computed tomography (CT) scan of the chest within 3 months prior to Screening
* In the opinion of the investigator, guideline-directed antibiotic therapy for treatment of MABc will not be required within the next 3 months, and a delay, in order for the subject to participate in a placebo-controlled clinical trial, is considered reasonable and clinically acceptable
Exclusion Criteria
* Has received systemic or inhaled antibiotic therapy (other than chronic macrolide therapy) within 4 weeks prior to Screening
* Has any of the following medical conditions:
* Active pulmonary malignancy, or any type of malignancy requiring chemotherapy or radiation within 1 year prior to Screening
* Active allergic bronchopulmonary mycosis, or any other condition requiring chronic treatment with systemic corticosteroids within 90 days prior to Screening
* Radiologic evidence of cavitary disease
* Known active pulmonary tuberculosis
* Cystic fibrosis
* History of lung transplantation
* Another advanced lung disease with a known percent predicted forced expiratory volume in 1 second \< 30%.
* Disseminated or extra-pulmonary NTM disease
* Has been previously treated with omadacycline
* Has a history of hypersensitivity or allergic reaction to tetracyclines
18 Years
ALL
No
Sponsors
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Paratek Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Amy Manley
Role: STUDY_CHAIR
Paratek Pharmaceuticals Inc
Locations
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Stanford University
Stanford, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
St. Francis Medical Institute
Clearwater, Florida, United States
University of Miami
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Infectious Disease Consultants of the Treasure Coast
Vero Beach, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Louisiana State University Medical Center Health Sciences Center-New Orleans Section of Pulmonary/Critical Care & Allergy/Immunology
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Northwell Health
New Hyde Park, New York, United States
Einstein/Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States
Countries
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References
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Jahanbakhsh S, Howland J, Ndayishimiye Uwineza MO, Thwaites MT, Pillar CM, Serio AW, Anastasiou DM, Hufnagel DA. Evaluation of omadacycline against intracellular Mycobacterium abscessus in an infection model in human macrophages. JAC Antimicrob Resist. 2023 Sep 15;5(5):dlad104. doi: 10.1093/jacamr/dlad104. eCollection 2023 Oct.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PTK0796-NTM-20203
Identifier Type: -
Identifier Source: org_study_id
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