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

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 and up

Participation Criteria

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