CAL02 for Bacterial Pneumonia

Recruiting at88 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Eagle Pharmaceuticals, Inc.

Disqualifiers: Ventilator pneumonia, Fungal pneumonia, Renal therapy, others

Prior Safety Data

Trial Summary

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.

Research Team

Valentin R Curt, MD

Principal Investigator

Eagle Pharmaceuticals, Inc.

Eligibility Criteria

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

I am over 18 years old.

I show signs of severe pneumonia, including symptoms, vital sign changes, or lab findings.

I have severe pneumonia needing intensive care or mechanical help to breathe.

Exclusion Criteria

Criterion: You are in the hospital and have certain lung infections, severe illness, specific medical conditions, or are pregnant.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 2 intravenous infusions of CAL02 or placebo, 24-26 hours apart, in addition to standard of care therapy for SCABP

1-2 days

2 visits (in-person)

Critical Care Management

Participants receive intensive and specialized medical and nursing care with continuous monitoring and organ support

28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of clinical recovery and adverse events

28 days

Treatment Details

Interventions

• CAL02 (Anti-infective Agent)
• Placebo (Other)

Trial Overview The trial is testing CAL02 in combination with standard treatments against a placebo plus standard treatments in patients with SCABP. The goal is to see if adding CAL02 improves outcomes for these critically ill patients.

Participant Groups

Group I: CAL02 with Standard of Care Experimental Treatment 1 Intervention

CAL02 (a mixture of 2 liposomal components, both empty, unilamellar, liposomes) will be administered as 2, IV infusions, 24 - 26 hours apart in addition to Standard of Care therapy for SCABP, according to scientific guidelines. CAL02 infusions will be administered over a 1 -2 hour period.

Group II: Placebo Placebo Group 1 Intervention

Placebo will be administered as 2, IV infusions, 24 - 26 hours apart in addition to Standard of Care therapy for SCABP, according to scientific guidelines. Placebo will be prepared and administered following the same infusion protocol as CAL02. Placebo infusions will be administered over a 1 to 2 hour period.

Who Is Running the Clinical Trial?

Eagle Pharmaceuticals, Inc.

Lead Sponsor

Trials

7

Recruited

1,000+