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Evaluating CAL02 treatment for severe 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)

Phase 2 Interventional Eagle Pharmaceuticals, Inc. · NCT05776004

This study is testing if adding a new treatment called CAL02 to standard care can help people with severe bacterial pneumonia feel better and recover faster.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment276 (estimated)
Ages18 Years and up
SexAll
SponsorEagle Pharmaceuticals, Inc. Industry-sponsored
Locations96 sites (Fresno, California and 95 other locations)
Trial IDNCT05776004 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of CAL02, an investigational treatment, when added to standard care for patients with severe community-acquired bacterial pneumonia (SCABP) requiring critical care. Participants will receive either CAL02 or a placebo in two intravenous infusions, alongside standard treatment protocols. The study aims to determine if CAL02 can improve outcomes for patients diagnosed with SCABP within 48 hours of hospital admission and exhibiting severe symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with severe community-acquired bacterial pneumonia requiring critical care.

Not a fit: Patients with mild pneumonia or those not requiring critical care measures may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery rates and outcomes for patients with severe bacterial pneumonia.

How similar studies have performed: Other studies have shown promise in treating severe pneumonia with novel therapies, but the specific approach of CAL02 is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* male or females older than 18 years old
* Body Weight 40 - 140 kg;
* clinical diagnosis of CABP diagnosed less than or equal to 48 hrs after hospital admission;
* presence of at least one of the protocol defined SCABP severity criteria:
* at least two clinical symptoms
* at least 2 vital sign abnormalities
* at least one finding of other clinical signs/laboratory abnormalities
* radiographic evidence in support of pneumonia with likely bacterial origin
* presence of at least one of the following severity criteria based on protocol defined SCABP:
* respiratory failure requiring invasive mechanical ventilation support
* respiratory failure requiring non-invasive positive pressure ventilation support
* respiratory failure requiring high-flow oxygen
* septic shock requiring treatment with vasopressors at therapeutic doses for at least 2 hours
* requires critical care for management of SCABP
* onset of severity criteria less than 48 hours from diagnosis of CABP or upon discussion with medical monitor
* written informed consent before any study-specific assessment is performed

Exclusion Criteria: Subjects in the hospital who meet any of the following criteria at screening and before study drug administration:

* subjects with ventilator-associated pneumonia, aspiration pneumonia, fungal pneumonia, viral pneumonia (viral coinfection may be exempted subject to discussion with medical monitor);
* subjects more than 12 hours from the diagnosis of SCABP;
* SOFA score greater than 12 points
* subject received IV antibiotics for CABP/SCABP for more than 48 hours at the time of randomization if sensitivity supports appropriate empiric therapy chosen and administered
* renal replacement therapy
* known hypersensitivity to liposomal formulations
* end-stage neuromuscular disorders, tracheostomy, known bronchial obstruction, post-operative aspiration pneumonia, cystic fibrosis, known or suspected pneumocystis jirovecii or tuberculosis pneumonia, post organ transplant, or primary or metastatic malignancy in the lungs
* current or recent participation in an investigational study (within 30 days of screening or 5 half-lives of the investigational compound, whichever is longer)
* known liver dysfunction, chronic liver disease with Child Pugh C or esophageal varices
* moribund clinical conditions at the time of screening or time of the first study medication infusion
* refractory septic shock at the time of randomization
* subject has any medical disease or condition that, in the opinion of the investigator, compromises the subject's safety or compromises the interpretation of results
* nursing and pregnant women
* women of childbearing potential and non-surgically sterile males

Where this trial is running

Fresno, California and 95 other locations

+46 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pneumonia, BacterialCommunity-Acquired
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.