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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04922554
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc

Study Description
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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)

Condition or disease Intervention/treatment Phase
Mycobacterium Infections, Nontuberculous Mycobacterium Abscessus Infection Nontuberculous Mycobacterial Lung Disease Nontuberculous Mycobacterial Pulmonary Infection Drug: Omadacycline Oral Tablet Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 15, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Omadacycline 300 mg PO
omadacycline 150 mg tablets (x 2) administered orally, once daily, q24h
 Drug: Omadacycline Oral Tablet
omadacycline 300 mg orally, once daily (150 mg tablets x 2)
Other Name: Nuzyra
Placebo Comparator: Placebo PO
Placebo tablets resembling omadacycline (x 2) administered once daily, q24h
 Drug: Placebo
placebo tablets resembling omadacycline orally, once daily (x 2 tablets)
Other Name: placebo tablets


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Response on NTM Symptom Assessment Scale at Day 84 [ Time Frame: Day 1 to Day 84/EOT ]
    Improvement in severity of at least 50% of symptoms present at baseline

  2. Reported adverse events (AEs) [ Time Frame: Day 1 to Day 84/EOT ]
    To assess reported adverse events

  3. Changes from baseline in laboratory tests [ Time Frame: Day 1 to Day 84/EOT ]
    To assess the incidents of abnormal hematology, biochemistry, coagulation and urinalysis assessments following 84 days of IP administration

  4. Clinically significant (CS), outside normal range laboratory tests [ Time Frame: Day 1 to Day 84/EOT ]
    To assess the incidents of CS abnormal hematology, biochemistry, coagulation and urinalysis assessments following 84 days of IP administration

  5. Changes from baseline in vital signs [ Time Frame: Day 1 to Day 84/EOT ]
    To assess the incidents of abnormal heart rate and blood pressure assessments following 84 days of IP administration

  6. Clinically significant (CS) vital signs [ Time Frame: Day 1 to Day 84/EOT ]
    To assess the incidents of CS heart rate and blood pressure following 84 days of IP administration

  7. Changes from baseline in electrocardiogram (ECG) [ Time Frame: Day 1 to Day 84/EOT ]
    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

  8. Clinically significant (CS) electrocardiogram (ECG) findings [ Time Frame: Day 1 to Day 84/EOT ]
    To assess the incidents of CS and QTc interval assessments following 84 days of IP administration


Secondary Outcome Measures :
  1. Change from baseline in the total score of the Quality of Life - Bronchiectasis (QOL-B) questionnaire [ Time Frame: Day 1 to Day 84/EOT ]
  2. 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 ]
  3. 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 ]
  4. Change from baseline in Patient Clinical Impression of Severity (PGI-S) [ Time Frame: Day 1 to Day 84/EOT ]
  5. Change from baseline in Patient Clinical Impression of Change (PGI-C) [ Time Frame: Day 1 to Day 84/EOT ]
  6. Change from baseline in Clinical Global Impression - Severity of Illness (CGI-S) [ Time Frame: Day 1 to Day 84/EOT ]
  7. Change from baseline in Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Day 1 to Day 84/EOT ]
  8. 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 ]
  9. Decrease in quantitative sputum culture at Day 84 [ Time Frame: Day 1 to Day 84/EOT ]
  10. Time to growth in liquid medium only [ Time Frame: Day 1 to Day 84/EOT ]
  11. Time to first negative sputum culture [ Time Frame: Day 1 to Day 84/EOT ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04922554


Contacts
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Contact: Alissa Sirbu 617.459.5307 alissa.sirbu@paratekpharma.com
Contact: Amy Manley 484.682.4976 amy.manley@paratekpharma.com

Locations
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Sponsors and Collaborators
Paratek Pharmaceuticals Inc
Investigators
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Study Chair: Gail Berman, MD Paratek Pharmaceuticals Inc
More Information
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Responsible Party: Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT04922554    
Other Study ID Numbers: PTK0796-NTM-20203
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paratek Pharmaceuticals Inc:
Nontuberculous Mycobacteria (NTM)
Mycobacterium abscessus complex (MABc)
NTM pulmonary disease
NTM lung disease
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Lung Diseases
Disease Attributes
 Pathologic Processes
Respiratory Tract Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses