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

Inclusion 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 Exclusion Criteria: Subjects in the hospital who meet any of the following criteria at screening and before study drug administration: * 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