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

Open to people ages 18 years and up

• 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 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