Mycobacterium Infections, NontuberculousPhase 2NCT04922554
Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
A Phase 2 study testing Omadacycline Oral Tablet in people with Mycobacterium Infections, Nontuberculous and Mycobacterium Abscessus Infection, run by Paratek Pharmaceuticals Inc at 17 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection, Nontuberculous Mycobacterial Lung Disease
- What is being tested?
- Omadacycline Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 17 sitesUnited States
- Study dates
- 15 Oct 2021to 17 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Emory University School of Medicine
Atlanta, Georgia, 30342
Johns Hopkins University
Baltimore, Maryland, 21287
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
St. Francis Medical Institute
Clearwater, Florida, 33765
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53792
University of Miami
Miami, Florida, 33136
Northwell Health
New Hyde Park, New York, 11042
Louisiana State University Medical Center Health Sciences Center-New Orleans Section of Pulmonary/Critical Care & Allergy/Immunology
New Orleans, Louisiana, 70112
Oregon Health & Science University
Portland, Oregon, 97239
Stanford University
Stanford, California, 94305
University of South Florida
Tampa, Florida, 33612
Einstein/Montefiore Medical Center
The Bronx, New York, 10467
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
Infectious Disease Consultants of the Treasure Coast
Vero Beach, Florida, 32960
Georgetown University Hospital
Washington D.C., District of Columbia, 20057
About this study
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
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)
Read the 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.
- Conditions
- Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection, Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterial Pulmonary Infection
- Being tested
- Omadacycline Oral Tablet, Placebo
- Keywords
- Nontuberculous Mycobacteria (NTM), Mycobacterium abscessus complex (MABc), NTM pulmonary disease, NTM lung disease
- Medical subject headings
- Mycobacterium Infections, Nontuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omadacycline Oral TabletDrug
Also called Nuzyra
omadacycline 300 mg orally, once daily (150 mg tablets x 2)
PlaceboDrug
Also called placebo tablets
placebo tablets resembling omadacycline orally, once daily (x 2 tablets)
| Study group | Role | What they receive |
|---|---|---|
| Omadacycline 300 mg PO | Experimental | omadacycline 150 mg tablets (x 2) administered orally, once daily, q24h Receives: Drug: Omadacycline Oral Tablet |
| Placebo PO | Placebo comparator | Placebo tablets resembling omadacycline (x 2) administered once daily, q24h Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Clinical Response on NTM Symptom Assessment Scale at Day 84
A clinical responder is defined as a participant who shows improvement in at least 50% of baseline symptoms on the NTM Symptom Assessment Questionnaire at the Day 84 Visit. This self-administered tool assesses 12 common NTM symptoms, each rated on a 4-point scale (absent, mild, moderate, severe), reflecting the participant's overall impression over the past week. The questionnaire is completed solely by the participant, without any interpretation from clinicians or site staff.
Measured: Day 1 to Day 84
Percentage of Participants With Clinical Response on NTM Symptom Assessment Scale at Day 84 With no Deterioration in Severity of Symptoms That Were Present at Baseline.
A clinical responder is defined as a participant who shows improvement in at least 50% of baseline symptoms with no deterioration of symptoms present at baseline on the NTM Symptom Assessment Questionnaire at the Day 84 Visit. This self-administered tool assesses 12 common NTM symptoms, each rated on a 4-point scale (absent, mild, moderate, severe), reflecting the participant's overall impression over the past week. The questionnaire is completed solely by the participant, without any interpretation from clinicians or site staff.
Measured: Day 1 to Day 84
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE is an adverse event that occurred on or after first dose of test article and those existing AEs that worsened on or after first dose of test article. An SAE is an adverse event that results in death, is life-threatening, requires hospitalization or extends an existing one, causes significant or lasting disability/incapacity, or leads to a congenital anomaly or birth defect. Additionally, events that may not meet these criteria but are medically significant can also be classified as SAEs.
Measured: From screening period (up to 8 weeks prior to randomization) through Day 114 (at any study timepoint)
Change From Baseline in Laboratory Test Parameters - Hepatic and Enzymatic Biomarkers
To assess the incidents of abnormal hepatic and enzymatic biomarkers following 84 days of IP administration
Measured: Day 1 (Baseline) to Day 84/EOT
Number of Participants With Potentially Clinically Significant (PCS) Laboratory Parameter
Laboratory PCS event is defined as at least a 2 grade increase from baseline based on the Division of Microbiology and Infectious Diseases (DMID) v5.0.
Measured: Day 1 through Day 84 (at any study timepoint)
Change From Baseline in Systolic and Diastolic Blood Pressure
To assess the incidents of abnormal blood pressure assessments following 84 days of IP administration
Measured: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in Heart Rate
To assess the incidents of abnormal heart rate following 84 days of IP administration
Measured: Day 1 (Baseline) to Day 84/EOT
Number of Participants With PCS Threshold Vital Signs Measurement
To assess the incidents of PCS heart rate and blood pressure following 84 days of IP administration
Measured: Day 1 through Day 84 (at any study timepoint)
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, and QTcF Interval
To assess the incidents of cardiac rhythm, PR interval, QRS interval, QT interval and QTc interval assessments following 84 days of IP administration
Measured: Day 1 (Baseline) to Day 84/EOT
Number of Participants With PCS QTcF Value
To assess the incidents of PCS and QTc interval assessments following 84 days of IP administration
Measured: Day 1 through Day 84/EOT (at any study timepoint)
Secondary outcomes (18)
Change From Baseline in the Total Score of the Quality of Life - Bronchiectasis (QOL-B) Questionnaire - Emotional Functioning Domain
The QOL-B is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for participants with non-cystic fibrosis bronchiectasis using a series of 37 questions. The QOL-B includes domains for physical functioning, role functioning, vitality, emotional functioning, social functioning, treatment burden, health perceptions and respiratory symptoms. For each domain, scores will be standardized on a 0 to 100 scale and higher scores represent better outcomes.
Measured: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in the Total Score of the QOL-B Questionnaire - Health Perceptions Domain
The QOL-B is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for participants with non-cystic fibrosis bronchiectasis using a series of 37 questions. The QOL-B includes domains for physical functioning, role functioning, vitality, emotional functioning, social functioning, treatment burden, health perceptions and respiratory symptoms. For each domain, scores will be standardized on a 0 to 100 scale and higher scores represent better outcomes.
Measured: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in the Total Score of the QOL-B Questionnaire - Physical Functioning Domain
The QOL-B is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for participants with non-cystic fibrosis bronchiectasis using a series of 37 questions. The QOL-B includes domains for physical functioning, role functioning, vitality, emotional functioning, social functioning, treatment burden, health perceptions and respiratory symptoms. For each domain, scores will be standardized on a 0 to 100 scale and higher scores represent better outcomes.
Measured: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in the Total Score of the QOL-B Questionnaire - Respiratory Symptoms Domain
The QOL-B is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for participants with non-cystic fibrosis bronchiectasis using a series of 37 questions. The QOL-B includes domains for physical functioning, role functioning, vitality, emotional functioning, social functioning, treatment burden, health perceptions and respiratory symptoms. For each domain, scores will be standardized on a 0 to 100 scale and higher scores represent better outcomes.
Measured: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in the Total Score of the QOL-B Questionnaire - Role Functioning Domain
The QOL-B is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for participants with non-cystic fibrosis bronchiectasis using a series of 37 questions. The QOL-B includes domains for physical functioning, role functioning, vitality, emotional functioning, social functioning, treatment burden, health perceptions and respiratory symptoms. For each domain, scores will be standardized on a 0 to 100 scale and higher scores represent better outcomes.
Measured: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in the Total Score of the QOL-B Questionnaire - Social Functioning Domain
The QOL-B is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for participants with non-cystic fibrosis bronchiectasis using a series of 37 questions. The QOL-B includes domains for physical functioning, role functioning, vitality, emotional functioning, social functioning, treatment burden, health perceptions and respiratory symptoms. For each domain, scores will be standardized on a 0 to 100 scale and higher scores represent better outcomes.
Measured: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in the Total Score of the QOL-B Questionnaire - Treatment Burden Domain
The QOL-B is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for participants with non-cystic fibrosis bronchiectasis using a series of 37 questions. The QOL-B includes domains for physical functioning, role functioning, vitality, emotional functioning, social functioning, treatment burden, health perceptions and respiratory symptoms. For each domain, scores will be standardized on a 0 to 100 scale and higher scores represent better outcomes.
Measured: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in the Total Score of the QOL-B Questionnaire - Vitality Domain
The QOL-B is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for participants with non-cystic fibrosis bronchiectasis using a series of 37 questions. The QOL-B includes domains for physical functioning, role functioning, vitality, emotional functioning, social functioning, treatment burden, health perceptions and respiratory symptoms. For each domain, scores will be standardized on a 0 to 100 scale and higher scores represent better outcomes.
Measured: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in Global Score and Individual Domain Scores of the SGRQ - Total Score
The SGRQ is a disease-specific, 50-item instrument designed to measure the impact of obstructive airways disease on overall health, daily life, and perceived well-being in participants. It consists of three domains: Symptoms (distress from respiratory symptoms), Activity (limitations in mobility and physical activity), and Impacts (effects on employment, self-management, and medication needs). Scores range from 0 (no impairment) to 100 (maximum impairment) for each domain. The SGRQ Total Score is calculated by dividing the total score values of all positive responses across all domains in the questionnaire by the maximum possible total score that a participant could have achieved, and then multiplying the result by 100. Higher scores indicate worse health status
Measured: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in Patient-Reported Outcomes Measurement Information System Short Form v1.0 - Fatigue 7a Daily (PROMIS-7a) Score
The PROMIS Fatigue is a self-administered questionnaire that assesses fatigue and its impact on physical, mental, and social activities. The fatigue short form is universal rather than disease-specific and assesses fatigue over the past 7 days. Participants respond to each of the 7 items using a 5-point Likert scale (e.g., "Not at all" to "Very much") and item responses are summed to produce a raw total score. Raw scores are converted to T-scores using standardized PROMIS scoring tables. The average change in PROMIS Fatigue T-scores was calculated for each study arm. The PROMIS Fatigue T-score is a standardized score (mean = 50, SD = 10) where higher scores indicate greater fatigue severity. A negative change from baseline (i.e., lower T-scores over time) indicates improvement in fatigue symptoms, whereas a positive change (i.e., higher T-scores) indicates worsening of fatigue.
Measured: Day 1 (Baseline) to Day 84/EOT
Number of Participants With Improvement in Patient Clinical Impression of Change (PGI-C)
The PGI-C is a self-administered, single question assessed using a 7-point scale that measures a participant's perceived change in clinical status and overall improvement. Participants with improvement includes: Very much improved, much improved, minimally improved; participants without improvement include: no change, minimally worse, much worse, very much worse.
Measured: Day 1 to Day 84/EOT
Number of Participants Reporting "Not Present or Mild Severity" in Patient Clinical Impression of Severity (PGI-S)
The PGI-S is a self-administered, single question assessed using a 7-point scale that measures a participant's perception of disease severity. Participants with severity Not present or Mild include: not present, very mild, mild; Participants with severity Moderate or Severe include: moderate, moderately severe, severe, extremely severe.
Measured: Day 84/EOT
Number of Participants With Clinical Global Impression - Severity of Illness (CGI-S)
The CGI-S is administered by an experienced clinician who is familiar with the disease under study. The CGI-S is a 1-item observer-rated scale that rates illness severity based upon observed and reported symptoms, behavior, and function over the past seven days.
Measured: Day 84/EOT
Number of Participants With Clinical Global Impression - Improvement (CGI-I)
The CGI-I is a single-item, observer-rated measure using a 7-point scale to assess overall improvement in a participant's condition due to drug treatment. Participants with improvement includes: very much improved, much improved, minimally improved; participants without improvement include: no change, minimally worse, much worse, very much worse.
Measured: Day 1 to Day 84/EOT
Number of Participants With New Symptoms With a Severity Worse Than Mild on the NTM Symptom Assessment Questionnaire at Any Time Post-baseline
The NTM symptom assessment questionnaire is a self-administered tool which assesses 12 common NTM symptoms on a 4-point scale (absent, mild, moderate, severe), reflecting the participant's overall impression over the past week. The questionnaire is completed solely by the participant, without any interpretation from clinicians or site staff.
Measured: Day 1 through Day 84 (at any study timepoint)
Number of Participants With Decreased Semi-Quantitative Score of Mycobacterial Sputum Culture From Day 1 to Day 84
Semi-quantitative score is derived based on growth in liquid medium, growth on agar plate, and colony count on agar plate; the score ranges from 0 to 6. A reduction in the semi-quantitative score reflects a decrease in the quantitative mycobacterial load.
Measured: Day 1 to Day 84
Time to Growth in Liquid Medium Only
Time to growth in liquid medium only is defined as the number of days from the date of study drug administration to the date of the first assessment where growth is detected in liquid medium only. The analysis was based on Kaplan Meier Estimation for Growth in Liquid Medium Only (Day). If there is no culture result indicating growth in liquid medium only and the culture plates are negative, the date of the first negative culture is used for determination of time to growth in liquid medium only.
Measured: Day 1 through Day 84 (at any study timepoint)
Time to First Negative Sputum Culture
Time to first negative sputum culture is defined as the number of days from the date of study drug administration to the date of the first negative sputum culture. The analysis was based on Kaplan Meier Estimation for Negative Sputum Culture (Day).
Measured: Day 1 through Day 84 (at any study timepoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start15 Oct 2021
- Primary completion17 Jun 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mycobacterium Infections, NontuberculousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paratek Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Manley, Study chair, Paratek Pharmaceuticals Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922554
- Sponsor's protocol ID
- PTK0796-NTM-20203
- Status last verified
- Jul 2025
- First submitted
- 18 May 2021
- Last updated
- 30 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37720564
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04922554
- Acronym / sponsor ID
- PTK0796-NTM-20203
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Paratek Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Posted 30 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omadacycline 300 mg PO | Experimental | Drug: Omadacycline Oral Tabletomadacycline 150 mg tablets (x 2) administered orally, once daily, q24h |
| Placebo PO | Placebo comparator | Drug: PlaceboPlacebo tablets resembling omadacycline (x 2) administered once daily, q24h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omadacycline Oral TabletAlso: Nuzyraomadacycline 300 mg orally, once daily (150 mg tablets x 2) | Drug | Omadacycline 300 mg PO |
| PlaceboAlso: placebo tabletsplacebo tablets resembling omadacycline orally, once daily (x 2 tablets) | Drug | Placebo PO |
Primary outcome
Percentage of Participants With Clinical Response on NTM Symptom Assessment Scale at Day 84
Time frame: Day 1 to Day 84
A clinical responder is defined as a participant who shows improvement in at least 50% of baseline symptoms on the NTM Symptom Assessment Questionnaire at the Day 84 Visit. This self-administered tool assesses 12 common NTM symptoms, each rated on a 4-point scale (absent, mild, moderate, severe), reflecting the participant's overall impression over the past week. The questionnaire is completed solely by the participant, without any interpretation from clinicians or site staff.
Percentage of Participants With Clinical Response on NTM Symptom Assessment Scale at Day 84 With no Deterioration in Severity of Symptoms That Were Present at Baseline.
Time frame: Day 1 to Day 84
A clinical responder is defined as a participant who shows improvement in at least 50% of baseline symptoms with no deterioration of symptoms present at baseline on the NTM Symptom Assessment Questionnaire at the Day 84 Visit. This self-administered tool assesses 12 common NTM symptoms, each rated on a 4-point scale (absent, mild, moderate, severe), reflecting the participant's overall impression over the past week. The questionnaire is completed solely by the participant, without any interpretation from clinicians or site staff.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From screening period (up to 8 weeks prior to randomization) through Day 114 (at any study timepoint)
A TEAE is an adverse event that occurred on or after first dose of test article and those existing AEs that worsened on or after first dose of test article. An SAE is an adverse event that results in death, is life-threatening, requires hospitalization or extends an existing one, causes significant or lasting disability/incapacity, or leads to a congenital anomaly or birth defect. Additionally, events that may not meet these criteria but are medically significant can also be classified as SAEs.
Change From Baseline in Laboratory Test Parameters - Hepatic and Enzymatic Biomarkers
Time frame: Day 1 (Baseline) to Day 84/EOT
To assess the incidents of abnormal hepatic and enzymatic biomarkers following 84 days of IP administration
Number of Participants With Potentially Clinically Significant (PCS) Laboratory Parameter
Time frame: Day 1 through Day 84 (at any study timepoint)
Laboratory PCS event is defined as at least a 2 grade increase from baseline based on the Division of Microbiology and Infectious Diseases (DMID) v5.0.
Change From Baseline in Systolic and Diastolic Blood Pressure
Time frame: Day 1 (Baseline) to Day 84/EOT
To assess the incidents of abnormal blood pressure assessments following 84 days of IP administration
Change From Baseline in Heart Rate
Time frame: Day 1 (Baseline) to Day 84/EOT
To assess the incidents of abnormal heart rate following 84 days of IP administration
Number of Participants With PCS Threshold Vital Signs Measurement
Time frame: Day 1 through Day 84 (at any study timepoint)
To assess the incidents of PCS heart rate and blood pressure following 84 days of IP administration
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, and QTcF Interval
Time frame: Day 1 (Baseline) to Day 84/EOT
To assess the incidents of cardiac rhythm, PR interval, QRS interval, QT interval and QTc interval assessments following 84 days of IP administration
Number of Participants With PCS QTcF Value
Time frame: Day 1 through Day 84/EOT (at any study timepoint)
To assess the incidents of PCS and QTc interval assessments following 84 days of IP administration
18 secondary outcomes
Change From Baseline in the Total Score of the Quality of Life - Bronchiectasis (QOL-B) Questionnaire - Emotional Functioning Domain
Time frame: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in the Total Score of the QOL-B Questionnaire - Health Perceptions Domain
Time frame: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in the Total Score of the QOL-B Questionnaire - Physical Functioning Domain
Time frame: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in the Total Score of the QOL-B Questionnaire - Respiratory Symptoms Domain
Time frame: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in the Total Score of the QOL-B Questionnaire - Role Functioning Domain
Time frame: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in the Total Score of the QOL-B Questionnaire - Social Functioning Domain
Time frame: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in the Total Score of the QOL-B Questionnaire - Treatment Burden Domain
Time frame: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in the Total Score of the QOL-B Questionnaire - Vitality Domain
Time frame: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in Global Score and Individual Domain Scores of the SGRQ - Total Score
Time frame: Day 1 (Baseline) to Day 84/EOT
Change From Baseline in Patient-Reported Outcomes Measurement Information System Short Form v1.0 - Fatigue 7a Daily (PROMIS-7a) Score
Time frame: Day 1 (Baseline) to Day 84/EOT
Number of Participants With Improvement in Patient Clinical Impression of Change (PGI-C)
Time frame: Day 1 to Day 84/EOT
Number of Participants Reporting "Not Present or Mild Severity" in Patient Clinical Impression of Severity (PGI-S)
Time frame: Day 84/EOT
Number of Participants With Clinical Global Impression - Severity of Illness (CGI-S)
Time frame: Day 84/EOT
Number of Participants With Clinical Global Impression - Improvement (CGI-I)
Time frame: Day 1 to Day 84/EOT
Number of Participants With New Symptoms With a Severity Worse Than Mild on the NTM Symptom Assessment Questionnaire at Any Time Post-baseline
Time frame: Day 1 through Day 84 (at any study timepoint)
Number of Participants With Decreased Semi-Quantitative Score of Mycobacterial Sputum Culture From Day 1 to Day 84
Time frame: Day 1 to Day 84
Time to Growth in Liquid Medium Only
Time frame: Day 1 through Day 84 (at any study timepoint)
Time to First Negative Sputum Culture
Time frame: Day 1 through Day 84 (at any study timepoint)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37720564Jahanbakhsh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Manley study chair
Paratek Pharmaceuticals Inc
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omadacycline Oral Tablet in people with Mycobacterium Infections, Nontuberculous and Mycobacterium Abscessus Infection, run by Paratek Pharmaceuticals Inc at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinical Response on NTM Symptom Assessment Scale at Day 84 (time frame: Day 1 to Day 84). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04922554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.