MedTrace Logo

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

NCT05776004 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2026-01-28

No results posted yet for this study

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

Conditions

  • Pneumonia, Bacterial

Interventions

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

Sponsors & Collaborators

  • Eagle Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Valentin R Curt, MD · Eagle Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-22
Primary Completion
2026-02-10
Completion
2026-09-07
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Czechia
  • France
  • Georgia
  • Greece
  • Hungary
  • Latvia
  • Peru
  • Romania
  • Serbia
  • Slovakia
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05776004 on ClinicalTrials.gov