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

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a placebo-controlled study to evaluate the addition of CAL02 to standard of care in treating hospitalized subjects diagnosed with severe community acquired bacterial pneumonia (SCABP) requiring critical care measures

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eagle Pharmaceuticals, Inc.

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