CAL02 for Bacterial Pneumonia

Recruiting in Palo Alto (17 mi)

+85 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Eagle Pharmaceuticals, Inc.

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.

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 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.

I was diagnosed with a lung infection within 2 days of being admitted to the hospital.

My weight is between 40 and 140 kg.

Exclusion Criteria

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

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CAL02 with Standard of CareExperimental Treatment1 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: PlaceboPlacebo Group1 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.