None listed
Conditions
Interventions
Subjects will be randomized (1:1) to 1 of the following 2 treatment arms:
• Omadacycline Powder for solution for infusion 100 mg iv q12h for 2 doses followed by 100 mg iv q24h (starting 24h after f
Sponsors
Paratek Pharma, LLC,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Written and signed informed consent must be obtained before any assessment is performed; 2. Male or female, age 18 years or older; 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: (a) Fever or hypothermia documented by the investigator (po or rectal temperature > 38.0°C [100.4°F] or 90 beats per minute (bpm); (d) Respiratory rate (RR) > 20 breaths/minute; 5. Has at least 1 clinical sign or laboratory finding associated with CABP: (a) Hypoxemia (partial pressure of arterial oxygen [PaO2]) 12,000 cells/mm3) or leucopenia (WBC 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 a highly effective form of birth control from Screening through post therapy evaluation (PTE). Males must agree to use a highly effective method of birth control with female partner(s) and must not donate sperm from Screening through PTE.
Exclusion criteria
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. 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: (a) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 × Upper Limit of Normal (ULN), (b) total bilirubin > 1.5 × ULN, or (c) 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, congestive heart failure, cardiac arrhythmia, etc.) within the 3 months prior to Screening; (7) Are diagnosed with long corrected QT interval (QTc) syndrome, use drugs of potential proarrhythmic or QTc 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 is known to have a calculated creatinine clearance (CrCl) of < 30 mL/minute, using the Cockcroft-Gault equation; (10) Evidence of significant immunological disease determined by any of the following: (a) Current or anticipated neutropenia defined as < 500 neutrophils/mm3; (b) Infection with Human Immunodeficiency Virus (HIV) and a cluster of differentiation 4 (CD4) count < 200 cells/mm3, or another Acquired Immune Deficiency Syndrome (AIDS)-defining illness; (c) 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
Countries
Argentina, Belgium, Bulgaria, Croatia, Czech Republic, Germany, Greece, Hungary, Israel, Korea South, Latvia, Mexico, Peru, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Taiwan, Turkey, Ukraine, United States
Contacts
Public ContactAndres Cesar Martin Bayona
PPD Peru S.A.C.
Outcome results
None listed