Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia

Eligibility Criteria

• * male or females older than 18 years old
• * Body Weight 40 - 140 kg;
• * clinical diagnosis of CABP diagnosed less than or equal to 48 hrs after hospital admission;
• * presence of at least one of the protocol defined SCABP severity criteria:
• * at least two clinical symptoms
• * at least 2 vital sign abnormalities
• * at least one finding of other clinical signs/laboratory abnormalities
• * radiographic evidence in support of pneumonia with likely bacterial origin
• * presence of at least one of the following severity criteria based on protocol defined SCABP:
• * respiratory failure requiring invasive mechanical ventilation support
• * respiratory failure requiring non-invasive positive pressure ventilation support
• * respiratory failure requiring high-flow oxygen
• * septic shock requiring treatment with vasopressors at therapeutic doses for at least 2 hours
• * requires critical care for management of SCABP
• * onset of severity criteria less than 48 hours from diagnosis of CABP or upon discussion with medical monitor
• * written informed consent before any study-specific assessment is performed
• * subjects with ventilator-associated pneumonia, aspiration pneumonia, fungal pneumonia, viral pneumonia (viral coinfection may be exempted subject to discussion with medical monitor);
• * subjects more than 12 hours from the diagnosis of SCABP;
• * SOFA score greater than 12 points
• * subject received IV antibiotics for CABP/SCABP for more than 48 hours at the time of randomization if sensitivity supports appropriate empiric therapy chosen and administered
• * renal replacement therapy
• * known hypersensitivity to liposomal formulations
• * end-stage neuromuscular disorders, tracheostomy, known bronchial obstruction, post-operative aspiration pneumonia, cystic fibrosis, known or suspected pneumocystis jirovecii or tuberculosis pneumonia, post organ transplant, or primary or metastatic malignancy in the lungs
• * current or recent participation in an investigational study (within 30 days of screening or 5 half-lives of the investigational compound, whichever is longer)
• * known liver dysfunction, chronic liver disease with Child Pugh C or esophageal varices
• * moribund clinical conditions at the time of screening or time of the first study medication infusion
• * refractory septic shock at the time of randomization
• * subject has any medical disease or condition that, in the opinion of the investigator, compromises the subject's safety or compromises the interpretation of results
• * nursing and pregnant women
• * women of childbearing potential and non-surgically sterile males