Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia
- Conditions
- Pneumonia, Bacterial
- Registration Number
- NCT05776004
- Lead Sponsor
- Eagle Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - male or females older than 18 years old<br><br> - Body Weight 40 - 140 kg;<br><br> - clinical diagnosis of CABP diagnosed less than or equal to 48 hrs after hospital<br> admission;<br><br> - presence of at least one of the protocol defined SCABP severity criteria:<br><br> - at least two clinical symptoms<br><br> - at least 2 vital sign abnormalities<br><br> - at least one finding of other clinical signs/laboratory abnormalities<br><br> - radiographic evidence in support of pneumonia with likely bacterial origin<br><br> - presence of at least one of the following severity criteria based on protocol<br> defined SCABP:<br><br> - respiratory failure requiring invasive mechanical ventilation support<br><br> - respiratory failure requiring non-invasive positive pressure ventilation support<br><br> - respiratory failure requiring high-flow oxygen<br><br> - septic shock requiring treatment with vasopressors at therapeutic doses for at least<br> 2 hours<br><br> - requires critical care for management of SCABP<br><br> - onset of severity criteria less than 48 hours from diagnosis of CABP or upon<br> discussion with medical monitor<br><br> - written informed consent before any study-specific assessment is performed<br><br>Exclusion Criteria: Subjects in the hospital who meet any of the following criteria at<br>screening and before study drug administration:<br><br> - subjects with ventilator-associated pneumonia, aspiration pneumonia, fungal<br> pneumonia, viral pneumonia (viral coinfection may be exempted subject to discussion<br> with medical monitor);<br><br> - subjects more than 12 hours from the diagnosis of SCABP;<br><br> - SOFA score greater than 12 points<br><br> - subject received IV antibiotics for CABP/SCABP for more than 48 hours at the time of<br> randomization if sensitivity supports appropriate empiric therapy chosen and<br> administered<br><br> - renal replacement therapy<br><br> - known hypersensitivity to liposomal formulations<br><br> - end-stage neuromuscular disorders, tracheostomy, known bronchial obstruction,<br> post-operative aspiration pneumonia, cystic fibrosis, known or suspected<br> pneumocystis jirovecii or tuberculosis pneumonia, post organ transplant, or primary<br> or metastatic malignancy in the lungs<br><br> - current or recent participation in an investigational study (within 30 days of<br> screening or 5 half-lives of the investigational compound, whichever is longer)<br><br> - known liver dysfunction, chronic liver disease with Child Pugh C or esophageal<br> varices<br><br> - moribund clinical conditions at the time of screening or time of the first study<br> medication infusion<br><br> - refractory septic shock at the time of randomization<br><br> - subject has any medical disease or condition that, in the opinion of the<br> investigator, compromises the subject's safety or compromises the interpretation of<br> results<br><br> - nursing and pregnant women<br><br> - women of childbearing potential and non-surgically sterile males
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy- clinical recovery;Incidence of Treatment-Emergent Adverse Events
- Secondary Outcome Measures
Name Time Method Critical Care Management;Hospital Stay;Early Clinical Recovery;Organ Failure Assessment Scores