Back to resultsOral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
Primary Purpose
Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection, Nontuberculous Mycobacterial Lung Disease
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omadacycline Oral Tablet
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mycobacterium Infections, Nontuberculous focused on measuring Nontuberculous Mycobacteria (NTM), Mycobacterium abscessus complex (MABc), NTM pulmonary disease, NTM lung disease
Eligibility Criteria
Key Inclusion Criteria:
- Has a diagnosis of Nontuberculous Mycobacterial pulmonary disease caused by MABc
- 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
- Additional inclusion criteria as per protocol
Key Exclusion Criteria:
- Has received antibiotic treatment within 6 months prior to Screening for MABc or MAC
- 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
- Additional exclusion criteria as per protocol
Sites / Locations
- University of Alabama Cystic Fibrosis Research Center
- Stanford UniversityRecruiting
- Georgetown University HospitalRecruiting
- Central Florida Pulmonary GroupRecruiting
- St. Francis Medical InstituteRecruiting
- University of Florida-College of Medicine- JacksonvilleRecruiting
- University of MiamiRecruiting
- Pasadena Center for Medical Research, LLCRecruiting
- University of South FloridaRecruiting
- Infectious Disease Consultants of the Treasure CoastRecruiting
- Emory University School of MedicineRecruiting
- University of Iowa Hospitals and ClinicsRecruiting
- Louisiana State University Medical Center Health Sciences Center-New Orleans Section of Pulmonary/Critical Care & Allergy/ImmunologyRecruiting
- Johns Hopkins UniversityRecruiting
- Washington University School of Medicine
- Dartmouth-Hitchcock Medical CenterRecruiting
- Einstein/Montefiore Medical CenterRecruiting
- Pulmonary Health Physicians, PCRecruiting
- Northwell HealthRecruiting
- University of North Carolina at Chapel Hill
- Southeastern Research Center
- Oregon Health & Science UniversityRecruiting
- Medical University of South Carolina (MUSC)Recruiting
- Vanderbilt University Medical CenterRecruiting
- Baylor University Medical Center / Baylor Scott and White Research Institute
- The University of Texas Health Science Center at TylerRecruiting
- University of Wisconsin Hospitals and ClinicsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omadacycline 300 mg PO
Placebo PO
Arm Description
omadacycline 150 mg tablets (x 2) administered orally, once daily, q24h
Placebo tablets resembling omadacycline (x 2) administered once daily, q24h
Outcomes
Primary Outcome Measures
Clinical Response on NTM Symptom Assessment Scale at Day 84
Improvement in severity of at least 50% of symptoms present at baseline
Reported adverse events (AEs)
To assess reported adverse events
Changes from baseline in laboratory tests
To assess the incidents of abnormal hematology, biochemistry, coagulation and urinalysis assessments following 84 days of IP administration
Clinically significant (CS), outside normal range laboratory tests
To assess the incidents of CS abnormal hematology, biochemistry, coagulation and urinalysis assessments following 84 days of IP administration
Changes from baseline in vital signs
To assess the incidents of abnormal heart rate and blood pressure assessments following 84 days of IP administration
Clinically significant (CS) vital signs
To assess the incidents of CS heart rate and blood pressure following 84 days of IP administration
Changes from baseline in electrocardiogram (ECG)
To assess the incidents of abnormal heart rate, cardiac rhythm, PR interval, RR interval, QRS interval, QT interval and QTc interval assessments following 84 days of IP administration
Clinically significant (CS) electrocardiogram (ECG) findings
To assess the incidents of CS and QTc interval assessments following 84 days of IP administration
Secondary Outcome Measures
Change from baseline in the total score of the Quality of Life - Bronchiectasis (QOL-B) questionnaire
Change from baseline in global score and individual domain scores of the St. George Respiratory Questionnaire (SGRQ)
Change from baseline in Patient-Reported Outcomes Measurement Information System Short Form v1.0 - Fatigue 7a Daily (PROMIS-7a)
Change from baseline in Patient Clinical Impression of Severity (PGI-S)
Change from baseline in Patient Clinical Impression of Change (PGI-C)
Change from baseline in Clinical Global Impression - Severity of Illness (CGI-S)
Change from baseline in Clinical Global Impression - Improvement (CGI-I)
Patients reporting no new symptoms with a severity worse than mild on the NTM Symptom Assessment Questionnaire
Decrease in quantitative sputum culture at Day 84
Time to growth in liquid medium only
Time to first negative sputum culture
Full Information
NCT ID
NCT04922554
First Posted
May 18, 2021
Last Updated
September 15, 2023
Sponsor
Paratek Pharmaceuticals Inc
1. Study Identification
Unique Protocol Identification Number
NCT04922554
Brief Title
Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Paratek Pharmaceuticals Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection, Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterial Pulmonary Infection
Keywords
Nontuberculous Mycobacteria (NTM), Mycobacterium abscessus complex (MABc), NTM pulmonary disease, NTM lung disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omadacycline 300 mg PO
Arm Type
Experimental
Arm Description
omadacycline 150 mg tablets (x 2) administered orally, once daily, q24h
Arm Title
Placebo PO
Arm Type
Placebo Comparator
Arm Description
Placebo tablets resembling omadacycline (x 2) administered once daily, q24h
Intervention Type
Drug
Intervention Name(s)
Omadacycline Oral Tablet
Other Intervention Name(s)
Nuzyra
Intervention Description
omadacycline 300 mg orally, once daily (150 mg tablets x 2)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo tablets
Intervention Description
placebo tablets resembling omadacycline orally, once daily (x 2 tablets)
Primary Outcome Measure Information:
Title
Clinical Response on NTM Symptom Assessment Scale at Day 84
Description
Improvement in severity of at least 50% of symptoms present at baseline
Time Frame
Day 1 to Day 84/EOT
Title
Reported adverse events (AEs)
Description
To assess reported adverse events
Time Frame
Day 1 to Day 84/EOT
Title
Changes from baseline in laboratory tests
Description
To assess the incidents of abnormal hematology, biochemistry, coagulation and urinalysis assessments following 84 days of IP administration
Time Frame
Day 1 to Day 84/EOT
Title
Clinically significant (CS), outside normal range laboratory tests
Description
To assess the incidents of CS abnormal hematology, biochemistry, coagulation and urinalysis assessments following 84 days of IP administration
Time Frame
Day 1 to Day 84/EOT
Title
Changes from baseline in vital signs
Description
To assess the incidents of abnormal heart rate and blood pressure assessments following 84 days of IP administration
Time Frame
Day 1 to Day 84/EOT
Title
Clinically significant (CS) vital signs
Description
To assess the incidents of CS heart rate and blood pressure following 84 days of IP administration
Time Frame
Day 1 to Day 84/EOT
Title
Changes from baseline in electrocardiogram (ECG)
Description
To assess the incidents of abnormal heart rate, cardiac rhythm, PR interval, RR interval, QRS interval, QT interval and QTc interval assessments following 84 days of IP administration
Time Frame
Day 1 to Day 84/EOT
Title
Clinically significant (CS) electrocardiogram (ECG) findings
Description
To assess the incidents of CS and QTc interval assessments following 84 days of IP administration
Time Frame
Day 1 to Day 84/EOT
Secondary Outcome Measure Information:
Title
Change from baseline in the total score of the Quality of Life - Bronchiectasis (QOL-B) questionnaire
Time Frame
Day 1 to Day 84/EOT
Title
Change from baseline in global score and individual domain scores of the St. George Respiratory Questionnaire (SGRQ)
Time Frame
Day 1 to Day 84/EOT
Title
Change from baseline in Patient-Reported Outcomes Measurement Information System Short Form v1.0 - Fatigue 7a Daily (PROMIS-7a)
Time Frame
Day 1 to Day 84/EOT
Title
Change from baseline in Patient Clinical Impression of Severity (PGI-S)
Time Frame
Day 1 to Day 84/EOT
Title
Change from baseline in Patient Clinical Impression of Change (PGI-C)
Time Frame
Day 1 to Day 84/EOT
Title
Change from baseline in Clinical Global Impression - Severity of Illness (CGI-S)
Time Frame
Day 1 to Day 84/EOT
Title
Change from baseline in Clinical Global Impression - Improvement (CGI-I)
Time Frame
Day 1 to Day 84/EOT
Title
Patients reporting no new symptoms with a severity worse than mild on the NTM Symptom Assessment Questionnaire
Time Frame
Day 1 to Day 84/EOT
Title
Decrease in quantitative sputum culture at Day 84
Time Frame
Day 1 to Day 84/EOT
Title
Time to growth in liquid medium only
Time Frame
Day 1 to Day 84/EOT
Title
Time to first negative sputum culture
Time Frame
Day 1 to Day 84/EOT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Has a diagnosis of Nontuberculous Mycobacterial pulmonary disease caused by MABc
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
Additional inclusion criteria as per protocol
Key Exclusion Criteria:
Has received antibiotic treatment within 6 months prior to Screening for MABc or MAC
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
Additional exclusion criteria as per protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alissa Sirbu
Phone
617.459.5307
Email
alissa.sirbu@paratekpharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Manley
Phone
484.682.4976
Email
amy.manley@paratekpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Berman, MD
Organizational Affiliation
Paratek Pharmaceuticals Inc
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Cystic Fibrosis Research Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Withdrawn
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Jacobs
Phone
650-725-8083
Email
ssjpulm@stanford.edu
First Name & Middle Initial & Last Name & Degree
Stephen Ruoss, MD
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amen Hamed
Phone
202-444-0895
Email
amen.m.hamed@gunet.georgetown.edu
First Name & Middle Initial & Last Name & Degree
Anne O'Donnell, MD
Facility Name
Central Florida Pulmonary Group
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daysi Guerrero
Phone
407-841-1100
Email
dguerrero@cfpulmonary.com
First Name & Middle Initial & Last Name & Degree
Francisco Calimano, MD
Facility Name
St. Francis Medical Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis J Averill, MD
Phone
727-210-4606
Email
faverillresearch@stfrancismed.com
First Name & Middle Initial & Last Name & Degree
Francis J Averill, MD
Facility Name
University of Florida-College of Medicine- Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandi Wells
Phone
904-244-1106
Email
brandi.wells@jax.ufl.edu
First Name & Middle Initial & Last Name & Degree
Mehdi Mirsaeidi, MD
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Whitaker
Phone
305-243-2568
Email
yiw2@miami.edu
First Name & Middle Initial & Last Name & Degree
Lisa Domaradzki, MD
Facility Name
Pasadena Center for Medical Research, LLC
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Aguas
Phone
727-347-5242
Ext
408
Email
angela.aguas@theiaclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Mohamed Ali, MD
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Montera
Phone
813-844-7948
Email
bmontera@usf.edu
First Name & Middle Initial & Last Name & Degree
Chakrapol Sriaroon, MD
Facility Name
Infectious Disease Consultants of the Treasure Coast
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Chaffee
Phone
772-299-7009
Ext
203
Email
infusions@idctc.com
First Name & Middle Initial & Last Name & Degree
Laurie Welton, MD
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Cox, CCMA
Phone
404-251-1705
Email
elizabeth.m.cox@emory.edu
First Name & Middle Initial & Last Name & Degree
Colin Swenson, MD
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devon Foster
Phone
319-353-7318
Email
devon-foster@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Douglas Hornick, MD
Facility Name
Louisiana State University Medical Center Health Sciences Center-New Orleans Section of Pulmonary/Critical Care & Allergy/Immunology
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Sandi
Phone
504-568-4634
Email
mchild@lsuhsc.edu
First Name & Middle Initial & Last Name & Degree
Juzar Ali, MD
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NTMBresearch
Phone
410-550-4968
Email
NTMBresearch@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Christopher Lippincott, MD
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haley Mitchell
Phone
603-650-5533
Email
haley.j.johnson@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Elizabeth Talbot, MD
Facility Name
Einstein/Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vimi Desai
Email
vimdesai@montefiore.org
First Name & Middle Initial & Last Name & Degree
Eric Meyerowitz, MD
Facility Name
Pulmonary Health Physicians, PC
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Thater
Phone
315-475-8402
Email
kristen.thater@sjhsyr.org
First Name & Middle Initial & Last Name & Degree
Sherif El Bayadi, MD
Facility Name
Northwell Health
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cara Fidnarick
Phone
516-465-5412
Email
cfidnari@northwell.edu
First Name & Middle Initial & Last Name & Degree
Natalie Rajcooar
Phone
516-465-5441
Email
nrajcooar@northwell.edu
First Name & Middle Initial & Last Name & Degree
Nicole Lapinel, MD
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackson Pettee
Phone
919-843-4450
First Name & Middle Initial & Last Name & Degree
Kenneth Olivier, MD
Facility Name
Southeastern Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Withdrawn
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ted Warnock, BS
Phone
503-494-8121
Email
warnockt@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Kevin Winthrop, MPH, MD
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Princeton McBride
Phone
843-792-3710
Email
mcbridpr@musc.edu
First Name & Middle Initial & Last Name & Degree
Patrick Flume, MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Briana Swanner
Phone
615-327-7232
Email
briana.swanner@vumc.org
First Name & Middle Initial & Last Name & Degree
Kelly Dooley, MD
Facility Name
Baylor University Medical Center / Baylor Scott and White Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States
Individual Site Status
Withdrawn
Facility Name
The University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Greeenlee, BS, CCRC
Phone
903-877-5986
Email
Kimberly.Greenlee@uthct.edu
First Name & Middle Initial & Last Name & Degree
Pamela McShane, MD
Facility Name
University of Wisconsin Hospitals and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Bialock
Phone
608-263-4818
Email
jbialock@clinicaltrials.wisc.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Ann Misch, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
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