CAL02 for Bacterial Pneumonia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if adding CAL02 to standard care helps patients with severe bacterial pneumonia who need intensive care. CAL02 is given through an IV and aims to help the body fight the infection better. CAL02 is a new treatment that helps the body fight infection by targeting harmful substances produced by bacteria.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Who Is on the Research Team?
Valentin R Curt, MD
Principal Investigator
Eagle Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
Adults over 18 with severe community-acquired bacterial pneumonia (SCABP) who were hospitalized within the last 48 hours and require critical care can join. They must weigh between 40-140 kg and give written consent. Excluded are those with certain types of pneumonia, a high SOFA score, prolonged IV antibiotic use for this condition, liver dysfunction, recent investigational study participation, or life-threatening medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 2 intravenous infusions of CAL02 or placebo, 24-26 hours apart, in addition to standard of care therapy for SCABP
Critical Care Management
Participants receive intensive and specialized medical and nursing care with continuous monitoring and organ support
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of clinical recovery and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- CAL02
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eagle Pharmaceuticals, Inc.
Lead Sponsor