A Phase 2 interventional study of Omadacycline Oral Tablet and Placebo in Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection and Nontuberculous Mycobacterial Lung Disease, sponsored by Paratek Pharmaceuticals Inc. Completed at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by Paratek Pharmaceuticals Inc · Phase 2, Interventional, and Treatment
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)
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.
54 studies on the registry are indexed under Mycobacterium Infections, Nontuberculous; 19 are open to participants now.
This study's enrollment of 66 is above the median of 40 across 35 interventional studies indexed under Mycobacterium Infections, Nontuberculous.
Browse Mycobacterium Infections, Nontuberculous studies →Paratek Pharmaceuticals Inc is the lead sponsor of 12 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
omadacycline 150 mg tablets (x 2) administered orally, once daily, q24h
Drug: Omadacycline Oral Tablet
Placebo tablets resembling omadacycline (x 2) administered once daily, q24h
Drug: Placebo
omadacycline 300 mg orally, once daily (150 mg tablets x 2)
Also known as: Nuzyra
placebo tablets resembling omadacycline orally, once daily (x 2 tablets)
Also known as: placebo tablets
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 through Day 84/EOT (at any study timepoint)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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
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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 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).
Time frame: Day 1 through Day 84 (at any study timepoint)
This is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of omadacycline in adult participants with nontuberculous mycobacterial pulmonary disease caused by Mycobacterium abscessus complex.
| Milestone | Omadacycline 300 mg | Placebo |
|---|---|---|
| Started | 41 | 25 |
| Completed | 36 | 25 |
| Not completed | 5 | 0 |
| Withdrew: Adverse event | 4 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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 | Omadacycline 300 mg | Placebo |
|---|---|---|
| Percentage of Participants With Clinical Response on NTM Symptom Assessment Scale at Day 84 | 34.1 | 20.0 |
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.
| percentage of participants | Omadacycline 300 mg | Placebo |
|---|---|---|
| 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. | 34.1 | 12.0 |
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.
| Participants | Omadacycline 300 mg | Placebo |
|---|---|---|
| TEAEs | 35 | 21 |
| SAEs | 0 | 2 |
To assess the incidents of abnormal hepatic and enzymatic biomarkers following 84 days of IP administration
| Units per litre | Omadacycline 300 mg | Placebo |
|---|---|---|
| Alkaline Phosphatase | -3.3 ± 14.46 | -3.0 ± 11.22 |
| Alanine Aminotransferase | 10.4 ± 17.19 | -1.4 ± 9.74 |
| Aspartate Aminotransferase | 3.9 ± 8.72 | -3.0 ± 11.88 |
| Creatine Kinase | 2.5 ± 28.76 | -26.6 ± 116.68 |
| Gamma Glutamyl Transferase | 1.7 ± 14.35 | -0.6 ± 12.83 |
| Lipase | 3.5 ± 16.50 | -2.2 ± 8.39 |
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.
| Participants | Omadacycline 300 mg | Placebo |
|---|---|---|
| Alkaline Phosphatase | 0 | 0 |
| Alanine Aminotransferase | 2 | 0 |
| Aspartate Aminotransferase | 0 | 0 |
| Calcium | 0 | 0 |
| Creatinine | 0 | 0 |
| Gamma Glutamyl Transferase | 0 | 0 |
| Lipase | 3 | 0 |
| Magnesium | 0 | 0 |
| Phosphate | 0 | 0 |
| Potassium | 0 | 0 |
| Sodium | 1 | 0 |
| Bilirubin | 0 | 0 |
| Neutrophils | 0 | 0 |
| Hemoglobin | 0 | 0 |
| Platelets | 0 | 0 |
| Leukocytes | 0 | 1 |
To assess the incidents of abnormal blood pressure assessments following 84 days of IP administration
| Millimeter of mercury | Omadacycline 300 mg | Placebo |
|---|---|---|
| Systolic Blood Pressure | 4.3 ± 12.53 | 2.4 ± 12.62 |
| Diastolic Blood Pressure | -0.5 ± 8.63 | 0.7 ± 10.45 |
To assess the incidents of abnormal heart rate following 84 days of IP administration
| Beats per minute | Omadacycline 300 mg | Placebo |
|---|---|---|
| Change From Baseline in Heart Rate | 1.1 ± 8.66 | 0.2 ± 10.09 |
To assess the incidents of PCS heart rate and blood pressure following 84 days of IP administration
| Participants | Omadacycline 300 mg | Placebo |
|---|---|---|
| Heart rate: >120 and increase of >=15 bpm | 0 | 0 |
| Heart rate: <=50 and decrease of >=15 bpm | 0 | 0 |
| Systolic blood pressure: >=180 and increase of >=20 mmHg | 0 | 0 |
| Systolic blood pressure: <=90 and decrease of >=20 mmHg | 0 | 0 |
| Diastolic blood pressure: >=105 and increase of >=15 mmHg | 0 | 0 |
| Diastolic blood pressure: <=50 and decrease of >=15 mmHg | 2 | 0 |
| Temperature: >38.0 | 0 | 0 |
| Temperature: <36.0 | 4 | 0 |
To assess the incidents of cardiac rhythm, PR interval, QRS interval, QT interval and QTc interval assessments following 84 days of IP administration
| milliseconds | Omadacycline 300 mg | Placebo |
|---|---|---|
| PR Interval | 9.7 ± 57.23 | 5.8 ± 40.93 |
| QRS Duration | -0.5 ± 9.23 | -2.3 ± 5.11 |
| QT Interval | -11.7 ± 18.66 | -2.0 ± 29.63 |
| QTcF Interval | -8.5 ± 34.04 | -7.3 ± 68.65 |
To assess the incidents of PCS and QTc interval assessments following 84 days of IP administration
| Participants | Omadacycline 300 mg | Placebo |
|---|---|---|
| > 450 msec | 3 | 5 |
| > 480 msec | 1 | 2 |
| > 500 msec | 1 | 0 |
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.
| Score on a scale | Omadacycline 300 mg | Placebo |
|---|---|---|
| Change From Baseline in the Total Score of the Quality of Life - Bronchiectasis (QOL-B) Questionnaire - Emotional Functioning Domain | 3.5 ± 2.05 | 2.7 ± 2.69 |
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.
| Score on a scale | Omadacycline 300 mg | Placebo |
|---|---|---|
| Change From Baseline in the Total Score of the QOL-B Questionnaire - Health Perceptions Domain | 4.2 ± 2.43 | -0.9 ± 3.25 |
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.
| Score on a scale | Omadacycline 300 mg | Placebo |
|---|---|---|
| Change From Baseline in the Total Score of the QOL-B Questionnaire - Physical Functioning Domain | 5.6 ± 3.21 | -2.7 ± 4.20 |
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.
| Score on a scale | Omadacycline 300 mg | Placebo |
|---|---|---|
| Change From Baseline in the Total Score of the QOL-B Questionnaire - Respiratory Symptoms Domain | 7.5 ± 2.10 | 2.0 ± 2.75 |
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.
| Score on a scale | Omadacycline 300 mg | Placebo |
|---|---|---|
| Change From Baseline in the Total Score of the QOL-B Questionnaire - Role Functioning Domain | 7.4 ± 2.14 | 0.9 ± 2.86 |
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.
| Score on a scale | Omadacycline 300 mg | Placebo |
|---|---|---|
| Change From Baseline in the Total Score of the QOL-B Questionnaire - Social Functioning Domain | 9.6 ± 2.45 | 2.6 ± 3.27 |
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.
| Score on a scale | Omadacycline 300 mg | Placebo |
|---|---|---|
| Change From Baseline in the Total Score of the QOL-B Questionnaire - Treatment Burden Domain | 2.8 ± 2.38 | 2.3 ± 3.20 |
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.
| Score on a scale | Omadacycline 300 mg | Placebo |
|---|---|---|
| Change From Baseline in the Total Score of the QOL-B Questionnaire - Vitality Domain | 9.3 ± 2.50 | -4.3 ± 3.27 |
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
| Score on a scale | Omadacycline 300 mg | Placebo |
|---|---|---|
| Activity score | -2.7 ± 2.50 | -3.6 ± 3.17 |
| Impact score | -3.7 ± 2.29 | -3.5 ± 2.99 |
| Symptom score | -5.6 ± 2.43 | -0.6 ± 3.11 |
| Total score | -3.7 ± 2.06 | -3.0 ± 2.67 |
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.
| score on a scale | Omadacycline 300 mg | Placebo |
|---|---|---|
| Change From Baseline in Patient-Reported Outcomes Measurement Information System Short Form v1.0 - Fatigue 7a Daily (PROMIS-7a) Score | -4.3 ± 1.01 | 1.3 ± 1.30 |
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.
| Participants | Omadacycline 300 mg | Placebo |
|---|---|---|
| Number of Participants With Improvement in Patient Clinical Impression of Change (PGI-C) | 31 | 9 |
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.
| Participants | Omadacycline 300 mg | Placebo |
|---|---|---|
| Number of Participants Reporting "Not Present or Mild Severity" in Patient Clinical Impression of Severity (PGI-S) | 26 | 12 |
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.
| Participants | Omadacycline 300 mg | Placebo |
|---|---|---|
| Normal, not at all ill | 14 | 4 |
| Borderline ill | 9 | 8 |
| Mildly ill | 11 | 9 |
| Moderately ill | 6 | 4 |
| Markedly ill | 0 | 0 |
| Severely ill | 1 | 0 |
| Among the most extremely ill participants | 0 | 0 |
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.
| Participants | Omadacycline 300 mg | Placebo |
|---|---|---|
| Number of Participants With Clinical Global Impression - Improvement (CGI-I) | 29 | 11 |
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.
| Participants | Omadacycline 300 mg | Placebo |
|---|---|---|
| Number of Participants With New Symptoms With a Severity Worse Than Mild on the NTM Symptom Assessment Questionnaire at Any Time Post-baseline | 4 | 6 |
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.
| Participants | Omadacycline 300 mg | Placebo |
|---|---|---|
| Number of Participants With Decreased Semi-Quantitative Score of Mycobacterial Sputum Culture From Day 1 to Day 84 | 26 | 11 |
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.
| Days | Omadacycline 300 mg | Placebo |
|---|---|---|
| Time to Growth in Liquid Medium Only | 34 (28 to 83) | NA (28 to NA) |
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).
| Days | Omadacycline 300 mg | Placebo |
|---|---|---|
| Time to First Negative Sputum Culture | 30 (28 to 84) | NA (30 to NA) |
Collected over Adverse events were monitored from screening period (up to 8 weeks prior to randomization) through the final Follow-up assessment, which occurred up to 30 days after the last dose of study treatment, with the treatment period lasting for 84 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omadacycline 300 mg | 0/41 (0%) | 0/41 (0%) | 35/41 (85.4%) |
| Placebo | 0/25 (0%) | 2/25 (8%) | 21/25 (84%) |
| Event | Omadacycline 300 mg | Placebo |
|---|---|---|
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/41 | 1/25 |
| COVID-19Infections and infestations | 0/41 | 1/25 |
| Event | Omadacycline 300 mg | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 22/41 | 2/25 |
| HeadacheNervous system disorders | 7/41 | 4/25 |
| FatigueGeneral disorders | 7/41 | 1/25 |
| Abdominal painGastrointestinal disorders | 6/41 | 1/25 |
| VomitingGastrointestinal disorders | 6/41 | 0/25 |
| DiarrhoeaGastrointestinal disorders | 5/41 | 1/25 |
| COVID-19Infections and infestations | 2/41 | 3/25 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 3/41 | 3/25 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/41 | 3/25 |
| Alanine aminotransferase increasedInvestigations | 4/41 | 0/25 |
Safety Analysis Set included all participants who received at least 1 dose of test article.
| Age, Continuous(Years) | Omadacycline 300 mg | Placebo | Total |
|---|---|---|---|
| Mean | 69.3 ± 9.61 | 72.8 ± 7.64 | 70.6 ± 9.02 |
| Sex: Female, Male(Participants) | Omadacycline 300 mg | Placebo | Total |
|---|---|---|---|
| Female | 30 | 15 | 45 |
| Male | 11 | 10 | 21 |
| Race (NIH/OMB)(Participants) | Omadacycline 300 mg | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 2 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 36 | 23 | 59 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Studies of the drug tested here: Omadacycline
Mycobacterium Infections, Nontuberculous →
Paratek Pharmaceuticals Inc