Clinical Trials List
Protocol NumberPTK0796-CABP-1200
NCT Number(ClinicalTrials.gov Identfier)NCT02531438
2015-09-01 - 2017-12-31
Phase III
Terminated5
ICD-10J15.9
Unspecified bacterial pneumonia
ICD-10J18.9
Pneumonia, unspecified organism
ICD-9482.9
Bacterial pneumonia, unspecified
A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects with Community-Acquired Bacterial Pneumonia (CABP)
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Trial Applicant
PPD DEVELOPMENT (HK) LIMITED
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Sponsor
Paratek Pharma, LLC
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Wei-Zhi Chen Division of Thoracic Medicine
- 蕭慈慧 Division of Thoracic Medicine
- Kang-Cheng Su Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
- 湯宏仁 Division of Infectious Disease
- Wei-Ting Chang Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Wen-Sen Lee Division of Infectious Disease
- Shian-Jiun Lin Division of Thoracic Medicine
- Chih-Hsin Lee Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
- 許甯傑 Division of General Surgery
- 莊祐中 Division of Thoracic Medicine
- 方震中 Division of Emergency Medicine
- 阮聖元 Division of Thoracic Medicine
- CHIEN-HUA HUANG Division of Emergency Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
The initial targeted indications are serious skin infections (ABSSSI), community acquired lower respiratory tract infections (CABP) and urinary tract infections
Objectives
Primary objective:
The primary objective of this study is to demonstrate that omadacycline
100 mg iv every 12 hours (q12h) for 2 doses, followed by 100 mg
iv/300 mg po once every 24 hours (q24h) is non-inferior to moxifloxacin
400 mg iv/po q24h in the treatment of adults with CABP.
Secondary objectives:
• To evaluate the safety of omadacycline in the treatment of adult
subjects with CABP in the Safety population.
• To evaluate the Clinical Response according to the identified
causative pathogen.
• To evaluate the pharmacokinetics (PK) of omadacycline in adult.
Test Drug
Omadacycline (PTK 0796)
Active Ingredient
Salt form: C29H40N4O7. C7H8O3S
Dosage Form
Injection
Dosage
100 mg/6 mL; 150mg
Endpoints
Successful Early Clinical Response (72-120 hours after first
dose) will be determined programmatically and defined as
survival with improvement in at least 2 of 4 subject
symptoms (cough, sputum production, pleuritic chest pain,
dyspnea), as assessed by the investigator, without
deterioration in any of these 4 symptoms.
Successful Investigator’s Assessment of Clinical Response
at the PTE visit, defined as survival after completion of a test
article regimen, with resolution of signs and symptoms of
the infection to the extent that further antibacterial therapy is
not necessary.
• Assessment of signs and symptoms of CABP by the
investigator
• Microbiological assessment of the infection
• Assessment of clinical respons
dose) will be determined programmatically and defined as
survival with improvement in at least 2 of 4 subject
symptoms (cough, sputum production, pleuritic chest pain,
dyspnea), as assessed by the investigator, without
deterioration in any of these 4 symptoms.
Successful Investigator’s Assessment of Clinical Response
at the PTE visit, defined as survival after completion of a test
article regimen, with resolution of signs and symptoms of
the infection to the extent that further antibacterial therapy is
not necessary.
• Assessment of signs and symptoms of CABP by the
investigator
• Microbiological assessment of the infection
• Assessment of clinical respons
Inclution Criteria
1.Written and signed informed consent must be obtained before any protocol specific assessment is performed.
2.Male or female, aged 18 years or older (The subject participating in this study in Taiwan must be over 20 years of age)
3.Has at least 3 of the following symptoms:
• Cough
• Production of purulent sputum
• Dyspnea (shortness of breath)
• Pleuritic chest pain.
4.Has at least TWO of the following abnormal vital signs
• Fever or hypothermia documented by the investigator (temperature > 38.0°C [100.4°F] or < 36.0°C [95.5°F])
• Hypotension with systolic blood pressure (SBP) < 90 mm Hg
• Heart rate > 90 bpm
• Respiratory rate (RR) > 20 breaths/minute.
5.Has at least 1 clinical sign or laboratory finding associated with CABP:
• Hypoxemia (partial pressure of arterial oxygen [PaO2] < 60 mm Hg by arterial blood gas [ABG] or oxygen saturation < 90% by pulse oximetry)
• Physical examination findings of pulmonary consolidation (eg, dullness on percussion, bronchial breath sounds, or egophony)
• An elevated total white blood cell (WBC) count (> 12,000 cells/mm3) or leucopenia (WBC < 4,000 cells/mm3) or elevated immature neutrophils (> 15% band forms regardless of total peripheral WBC count).
6.Radiographically-confirmed pneumonia, ie, new or progressive pulmonary infiltrate(s) on chest X-ray (CXR) or chest computed tomography (CT) scan consistent with acute bacterial pneumonia within 24 hours prior to the first dose of test article.
7.Has disease categorized as being PORT Risk Class II, III, or IV at Screening.
8.Is expected to require a minimum of at least 3 days of iv therapy for the initial treatment of CABP.
9.Females must have a negative urine pregnancy test at Screening and agree to comply with using an acceptable method of birth control as per your local requirements (eg, abstinence, po contraceptive, intrauterine device [IUD], barrier contraception [condom], tubal ligation, hysterectomy, bilateral oophorectomy, postmenopausal or vasectomized partner) from Screening through post therapy evaluation (PTE). Males must agree to use an acceptable method of birth control with female partner(s) and must not donate sperm from Screening through PTE.
2.Male or female, aged 18 years or older (The subject participating in this study in Taiwan must be over 20 years of age)
3.Has at least 3 of the following symptoms:
• Cough
• Production of purulent sputum
• Dyspnea (shortness of breath)
• Pleuritic chest pain.
4.Has at least TWO of the following abnormal vital signs
• Fever or hypothermia documented by the investigator (temperature > 38.0°C [100.4°F] or < 36.0°C [95.5°F])
• Hypotension with systolic blood pressure (SBP) < 90 mm Hg
• Heart rate > 90 bpm
• Respiratory rate (RR) > 20 breaths/minute.
5.Has at least 1 clinical sign or laboratory finding associated with CABP:
• Hypoxemia (partial pressure of arterial oxygen [PaO2] < 60 mm Hg by arterial blood gas [ABG] or oxygen saturation < 90% by pulse oximetry)
• Physical examination findings of pulmonary consolidation (eg, dullness on percussion, bronchial breath sounds, or egophony)
• An elevated total white blood cell (WBC) count (> 12,000 cells/mm3) or leucopenia (WBC < 4,000 cells/mm3) or elevated immature neutrophils (> 15% band forms regardless of total peripheral WBC count).
6.Radiographically-confirmed pneumonia, ie, new or progressive pulmonary infiltrate(s) on chest X-ray (CXR) or chest computed tomography (CT) scan consistent with acute bacterial pneumonia within 24 hours prior to the first dose of test article.
7.Has disease categorized as being PORT Risk Class II, III, or IV at Screening.
8.Is expected to require a minimum of at least 3 days of iv therapy for the initial treatment of CABP.
9.Females must have a negative urine pregnancy test at Screening and agree to comply with using an acceptable method of birth control as per your local requirements (eg, abstinence, po contraceptive, intrauterine device [IUD], barrier contraception [condom], tubal ligation, hysterectomy, bilateral oophorectomy, postmenopausal or vasectomized partner) from Screening through post therapy evaluation (PTE). Males must agree to use an acceptable method of birth control with female partner(s) and must not donate sperm from Screening through PTE.
Exclusion Criteria
1.Has received 1 or more dose(s) of a potentially effective systemic antibacterial treatment within the 72 hours prior to the first dose of test article (a subject will be considered to have received a potentially effective systemic antibacterial treatment if the pathogen identified as causing infection is shown to be susceptible to the antibacterial given or, in the circumstance where a pathogen is not identified, if the antibacterial agent is approved for treatment of pneumonia or is known to have activity against any of the leading causes of CABP [eg, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Legionella pneumophila]). EXCEPTION: Subjects may be eligible despite prior antibacterial therapy if they have been treated with a single dose of a short-acting antibacterial (ie, an antibacterial whose standard dosing regimen is more frequent than once per day).
2.Is known or suspected to have CABP caused by a pathogen that may be resistant to either test article (eg, Klebsiella pneumoniae, Pseudomonas aeruginosa, Pneumocystis jiroveci, obligate anaerobes, mycobacteria, fungal pathogens).
3.Suspected or confirmed empyema (a parapneumonic pleural effusion is not an exclusion criteria) or lung abscess.
4.Subjects with known or suspected hospital-acquired pneumonia (HAP) or healthcare-associated pneumonia (HCAP). HAP is defined as pneumonia with onset of clinical signs and symptoms ≥ 48 hours after hospitalization in an acute in-subject health care facility. HCAP is defined as pneumonia acquired in a long-term care or subacute/intermediate healthcare facility (eg, nursing home) or in a subject admitted with pneumonia following a recent hospitalization (discharged within 90 days of current admission and previously hospitalized for ≥ 48 hours).
5.Has known or is clinically suspected to have 1 or more of the following prior to randomization:
• ALT or aspartate aminotransferase (AST) ≥ 2 × Upper Limit of Normal (ULN),
• total bilirubin > 1.5 × ULN, or
• evidence of end-stage liver disease (eg, ascites, hepatic encephalopathy).
6.Has a known history of having experienced unstable cardiac disease (eg, unstable angina, myocardial infarction, acute congestive heart failure, unstable cardiac arrhythmia, etc.) within the 3 months prior to Screening.
7.Has a QT interval corrected for heart rate using Fridericia’s formula (QTcF) > 450 msec (males) or > 470 msec (females), are known to have long QT syndrome, use drugs of potential proarrhythmic or QT prolonging effect and/or present with tachyarrhythmia.
8.Requires any form of dialysis (eg, hemodialysis, peritoneal dialysis).
9.History or evidence of severe renal disease or has a calculated creatinine clearance (CrCL) < 30 mL/minute, using the Cockcroft-Gault equation.
10.Evidence of significant immunologic disease determined by any of the following:
• Current or anticipated neutropenia defined as < 500 neutrophils/mm3
• known infection with human immunodeficiency virus (HIV) and a cluster of differentiation 4 (CD4) count that is unknown or documented to be < 200 cells/mm3 within the last year, or an Acquired Immune Deficiency Syndrome (AIDS)-defining illness
• The receipt of cancer chemotherapy, radiotherapy, or potent, non-corticosteroid immunosuppressant drugs (eg, cyclosporine, azathioprine, tacrolimus, immune-modulating monoclonal antibody therapy, etc.) within the past 3 months, or the receipt of corticosteroids equivalent to or greater than 40 mg of prednisone per day or for more than 14 days in the prior 30 days.
11.Requires acute pharmacologic intervention to stabilize blood pressure (BP) and/or adequate tissue perfusion, OR has evidence of septic shock, defined by ALL of the following:
• Fever or hypothermia documented by the investigator (temperature > 38.0°C [100.4°F] or < 36.0°C [95.5°F])
• Heart rate > 90 beats/minute
• RR > 20 breaths/minute
• WBC > 12,000 cells/mm3 or < 4000 cells/mm3 or > 10% immature [band] forms regardless of the total peripheral WBC count
• Hypotension with SBP < 90 mm Hg despite an iv fluid challenge of 20-30 cc/kg over a 30 minute period
• Perfusion abnormalities that may include but are not limited to lactic acidosis (blood lactate concentration ≥ 4 mmol/L), oliguria, or acute alteration in mental status.
12.Known or suspected primary or metastatic neoplastic lung disease, aspiration pneumonia, active tuberculosis, cystic fibrosis, bronchiectasis, bronchial obstruction (eg, post-obstructive pneumonia), chronic neurological disorder preventing clearance of pulmonary secretions, or severe chronic obstructive pulmonary disease (COPD).
13.Pregnant or nursing (breastfeeding) women.
14.Has a history of hypersensitivity or allergic reaction (eg, anaphylaxis, urticaria, other significant reaction) to any tetracycline (eg, minocycline, doxycycline or tigecycline) or to any fluoroquinolone antibiotic.
15.Has a history of pseudotumor cerebri, or prior (within 2 weeks prior to Screening) or planned concomitant use of isotretinoin.
16.Has a history of systemic lupus erythematosus or lupus-like syndrome.
17.Has current evidence of pancreatitis.
18.Has a history of a central nervous system disorder that may predispose to seizures or lower the seizure threshold.
19.Use of other investigational drugs within 5 half-lives or 30 days prior to Screening, whichever is longer.
20.Has previously been treated with omadacycline or previously enrolled in this study.
21.Any planned medical intervention that might interfere with the ability to comply with the study requirements.
22.Has a life expectancy of less than or equal to 3 months or any concomitant condition that, in the opinion of the investigator, is likely to interfere with evaluation of the response of the infection under study, determination of AEs, or completion of the expected course of treatment.
2.Is known or suspected to have CABP caused by a pathogen that may be resistant to either test article (eg, Klebsiella pneumoniae, Pseudomonas aeruginosa, Pneumocystis jiroveci, obligate anaerobes, mycobacteria, fungal pathogens).
3.Suspected or confirmed empyema (a parapneumonic pleural effusion is not an exclusion criteria) or lung abscess.
4.Subjects with known or suspected hospital-acquired pneumonia (HAP) or healthcare-associated pneumonia (HCAP). HAP is defined as pneumonia with onset of clinical signs and symptoms ≥ 48 hours after hospitalization in an acute in-subject health care facility. HCAP is defined as pneumonia acquired in a long-term care or subacute/intermediate healthcare facility (eg, nursing home) or in a subject admitted with pneumonia following a recent hospitalization (discharged within 90 days of current admission and previously hospitalized for ≥ 48 hours).
5.Has known or is clinically suspected to have 1 or more of the following prior to randomization:
• ALT or aspartate aminotransferase (AST) ≥ 2 × Upper Limit of Normal (ULN),
• total bilirubin > 1.5 × ULN, or
• evidence of end-stage liver disease (eg, ascites, hepatic encephalopathy).
6.Has a known history of having experienced unstable cardiac disease (eg, unstable angina, myocardial infarction, acute congestive heart failure, unstable cardiac arrhythmia, etc.) within the 3 months prior to Screening.
7.Has a QT interval corrected for heart rate using Fridericia’s formula (QTcF) > 450 msec (males) or > 470 msec (females), are known to have long QT syndrome, use drugs of potential proarrhythmic or QT prolonging effect and/or present with tachyarrhythmia.
8.Requires any form of dialysis (eg, hemodialysis, peritoneal dialysis).
9.History or evidence of severe renal disease or has a calculated creatinine clearance (CrCL) < 30 mL/minute, using the Cockcroft-Gault equation.
10.Evidence of significant immunologic disease determined by any of the following:
• Current or anticipated neutropenia defined as < 500 neutrophils/mm3
• known infection with human immunodeficiency virus (HIV) and a cluster of differentiation 4 (CD4) count that is unknown or documented to be < 200 cells/mm3 within the last year, or an Acquired Immune Deficiency Syndrome (AIDS)-defining illness
• The receipt of cancer chemotherapy, radiotherapy, or potent, non-corticosteroid immunosuppressant drugs (eg, cyclosporine, azathioprine, tacrolimus, immune-modulating monoclonal antibody therapy, etc.) within the past 3 months, or the receipt of corticosteroids equivalent to or greater than 40 mg of prednisone per day or for more than 14 days in the prior 30 days.
11.Requires acute pharmacologic intervention to stabilize blood pressure (BP) and/or adequate tissue perfusion, OR has evidence of septic shock, defined by ALL of the following:
• Fever or hypothermia documented by the investigator (temperature > 38.0°C [100.4°F] or < 36.0°C [95.5°F])
• Heart rate > 90 beats/minute
• RR > 20 breaths/minute
• WBC > 12,000 cells/mm3 or < 4000 cells/mm3 or > 10% immature [band] forms regardless of the total peripheral WBC count
• Hypotension with SBP < 90 mm Hg despite an iv fluid challenge of 20-30 cc/kg over a 30 minute period
• Perfusion abnormalities that may include but are not limited to lactic acidosis (blood lactate concentration ≥ 4 mmol/L), oliguria, or acute alteration in mental status.
12.Known or suspected primary or metastatic neoplastic lung disease, aspiration pneumonia, active tuberculosis, cystic fibrosis, bronchiectasis, bronchial obstruction (eg, post-obstructive pneumonia), chronic neurological disorder preventing clearance of pulmonary secretions, or severe chronic obstructive pulmonary disease (COPD).
13.Pregnant or nursing (breastfeeding) women.
14.Has a history of hypersensitivity or allergic reaction (eg, anaphylaxis, urticaria, other significant reaction) to any tetracycline (eg, minocycline, doxycycline or tigecycline) or to any fluoroquinolone antibiotic.
15.Has a history of pseudotumor cerebri, or prior (within 2 weeks prior to Screening) or planned concomitant use of isotretinoin.
16.Has a history of systemic lupus erythematosus or lupus-like syndrome.
17.Has current evidence of pancreatitis.
18.Has a history of a central nervous system disorder that may predispose to seizures or lower the seizure threshold.
19.Use of other investigational drugs within 5 half-lives or 30 days prior to Screening, whichever is longer.
20.Has previously been treated with omadacycline or previously enrolled in this study.
21.Any planned medical intervention that might interfere with the ability to comply with the study requirements.
22.Has a life expectancy of less than or equal to 3 months or any concomitant condition that, in the opinion of the investigator, is likely to interfere with evaluation of the response of the infection under study, determination of AEs, or completion of the expected course of treatment.
The Estimated Number of Participants
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Taiwan
18 participants
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Global
750 participants
