What side effects are associated with this type of intervention?

Common treatments for bacterial pneumonia, primarily antibiotics such as beta-lactams, macrolides, and fluoroquinolones, can cause side effects including gastrointestinal upset (nausea, vomiting, diarrhea), allergic reactions (rash, anaphylaxis), and more severe effects like Clostridioides difficile infection, tendonitis, or QT prolongation. Anti-inflammatory agents like corticosteroids, used adjunctively, may lead to hyperglycemia, increased infection risk, and osteoporosis with prolonged use.

What prior FDA approvals exist?

FDA-approved treatments for bacterial pneumonia typically include antibiotics such as penicillins, cephalosporins, macrolides, and fluoroquinolones, which target bacterial pathogens directly. While CAL02 is a novel anti-virulence agent designed to neutralize bacterial toxins and reduce inflammation, similar mechanisms are not commonly the primary focus of existing FDA-approved treatments. Instead, current treatments aim to eradicate the bacterial infection itself. However, supportive therapies that reduce inflammation and tissue damage, such as corticosteroids, may be used adjunctively in severe cases.

What other types of research exist?

Promising novel alternatives to CAL02 for bacterial pneumonia patients include: 1) MTD12813, a theta-defensin inspired cyclic peptide that enhances survival by promoting host-mediated bacterial clearance and modulating cytokine responses. 2) PA-13, a hybrid antimicrobial peptide that exhibits membrane-active mechanisms and neutralizes lipopolysaccharides, reducing inflammation. 3) SAL200, a recombinant endolysin derived from phage, effective against Staphylococcus aureus pneumonia by breaking down bacterial cell walls.

← Back to Search

Anti-infective Agent

CAL02 for Bacterial Pneumonia

Phase 2

Recruiting

Research Sponsored by Eagle Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of CAL02 aren't listed here, participants may experience reactions related to the drug or its liposomal formulation. Standard care side effects will also apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

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

Select...

My weight is between 40 and 140 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy- clinical recovery

Incidence of Treatment-Emergent Adverse Events

Secondary study objectives

Critical Care Management

Early Clinical Recovery

Hospital Stay

+1 more

Trial Design

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for bacterial pneumonia include antibiotics like beta-lactams, macrolides, and fluoroquinolones. Beta-lactams, such as penicillins and cephalosporins, inhibit bacterial cell wall synthesis, leading to cell lysis and death. Macrolides, like azithromycin, inhibit protein synthesis by binding to the bacterial ribosome, thereby preventing bacterial growth. Fluoroquinolones, such as levofloxacin, inhibit DNA gyrase and topoisomerase IV, enzymes critical for bacterial DNA replication. These mechanisms are crucial for effectively eliminating the bacterial infection, reducing symptoms, and preventing complications. In contrast, CAL02, a novel anti-virulence agent, neutralizes bacterial toxins, reducing inflammation and tissue damage without directly killing the bacteria. This approach can be particularly beneficial in severe infections where inflammation and toxin-mediated damage are significant concerns.

How radiotherapy was historically used to treat pneumonia: could it be useful today?