NCT05776004

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

A Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of CAL02 Administered Intravenously in Addition to Standard of Care in Subjects With Severe Community-Acquired Bacterial Pneumonia (SCABP)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Eagle Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Subjects diagnosed with SCABP and requiring critical care measures, will receive either 2 intravenous infusions of CAL02 (13.7 to 24 mg/kg bracketed dose by weight), administered 24-26 hours apart or 2 intravenous infusions of placebo. Additionally, all subjects will receive standard of care (SOC) therapy for SCABP, according to scientific guidelines. Critical care measures provide intensive and specialized medical and nursing care, a capacity for continuous monitoring 24 hours/day, and multiple modalities of physiologic organ support to sustain life in seriously/critically ill patients.

Conditions

• Pneumonia, Bacterial

Interventions

Type	Name	Description
DRUG	CAL02	CAL02 consists of a mixture of 2 liposomes and is a non-biological bacterial virulence neutralizer.
DRUG	Placebo	Physiological 0.9% sodium chloride solution for iv administration

Timeline

• Start date: 2023-07-22
• Primary completion: 2026-02-10
• Completion: 2026-09-07
• First posted: 2023-03-20
• Last updated: 2026-01-28

Locations

90 sites across 19 countries: United States, Argentina, Belgium, Brazil, Canada, Chile, Colombia, Czechia, France, Georgia, Greece, Hungary, Latvia, Peru, Romania, Serbia, Slovakia, South Africa, Spain

Regulatory

• FDA-regulated drug study