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

PHASE2CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

October 15, 2021

Primary Completion Date

June 17, 2024

Study Completion Date

July 17, 2024

Conditions
Mycobacterium Infections, NontuberculousMycobacterium Abscessus InfectionNontuberculous Mycobacterial Lung DiseaseNontuberculous 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)

Trial Locations (17)

10467

Einstein/Montefiore Medical Center, The Bronx

11042

Northwell Health, New Hyde Park

20057

Georgetown University Hospital, Washington D.C.

21287

Johns Hopkins University, Baltimore

27599

University of North Carolina at Chapel Hill, Chapel Hill

29425

Medical University of South Carolina (MUSC), Charleston

30342

Emory University School of Medicine, Atlanta

32960

Infectious Disease Consultants of the Treasure Coast, Vero Beach

33136

University of Miami, Miami

33612

University of South Florida, Tampa

33765

St. Francis Medical Institute, Clearwater

53792

University of Wisconsin Hospitals and Clinics, Madison

70112

Louisiana State University Medical Center Health Sciences Center-New Orleans Section of Pulmonary/Critical Care & Allergy/Immunology, New Orleans

75708

The University of Texas Health Science Center at Tyler, Tyler

94305

Stanford University, Stanford

97239

Oregon Health & Science University, Portland

03756

Dartmouth-Hitchcock Medical Center, Lebanon

Sponsors
All Listed Sponsors
lead

Paratek Pharmaceuticals Inc

INDUSTRY