CAL02 for Bacterial Pneumonia

Not currently recruiting at 98 trial locations

Overseen By Valentin R Curt, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eagle Pharmaceuticals, Inc.

Disqualifiers: Ventilator pneumonia, Fungal pneumonia, Renal therapy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1-2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CAL02 for individuals with severe community-acquired bacterial pneumonia, a type of lung infection. The researchers aim to determine if adding CAL02 to standard care improves recovery compared to standard treatment alone. Participants will receive either CAL02 or a placebo (a substance with no active effect) through IV infusions alongside their regular pneumonia care. This trial suits individuals hospitalized with a recent pneumonia diagnosis who require critical care, such as breathing support or medication to maintain blood pressure. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important medical advancements.

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.

Is there any evidence suggesting that CAL02 is likely to be safe for humans?

Research shows that CAL02, a new treatment for severe bacterial pneumonia, has undergone previous safety testing. Studies have examined patient responses to various doses of CAL02, and results indicate that most patients tolerate it well. Serious side effects were rare, though some reported mild issues like headaches or nausea, which were uncommon.

CAL02's current phase of testing indicates it has demonstrated some safety in earlier research. While not entirely risk-free, it has passed initial safety checks. As with any treatment, discussing potential risks and benefits with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for bacterial pneumonia, which typically involves antibiotics, CAL02 is unique because it uses a novel mechanism to combat infection. CAL02 consists of liposomes that act like decoys, capturing bacterial toxins and neutralizing them before they can damage cells. Researchers are excited about CAL02 because it offers a new way to treat bacterial pneumonia, potentially enhancing the effectiveness of existing antibiotic therapies and reducing the risk of antibiotic resistance. Additionally, CAL02's infusion method allows it to work quickly, aiming to deliver results in just a couple of days.

What evidence suggests that CAL02 might be an effective treatment for bacterial pneumonia?

This trial will compare CAL02 with a placebo in treating severe bacterial pneumonia. Research has shown that CAL02 might help treat severe bacterial pneumonia by targeting and neutralizing harmful substances produced by bacteria. These substances can cause significant damage during infections. CAL02 disarms these harmful substances without directly killing the bacteria, differing from antibiotics. Early findings from a study showed that patients receiving CAL02 tolerated it well, with some improvements in their pneumonia symptoms. While detailed data is still being collected, early results are promising for its potential effectiveness. ^{1 2 4 5 6}

Who Is on the Research Team?

Valentin R Curt, MD

Principal Investigator

Eagle Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

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 am over 18 years old.

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.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 2 intravenous infusions of CAL02 or placebo, 24-26 hours apart, in addition to standard of care therapy for SCABP

1-2 days

2 visits (in-person)

Critical Care Management

Participants receive intensive and specialized medical and nursing care with continuous monitoring and organ support

28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of clinical recovery and adverse events

28 days

What Are the Treatments Tested in This Trial?

Interventions

• CAL02
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: CAL02 with Standard of Care Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Eagle Pharmaceuticals, Inc.

Lead Sponsor

Trials

7

Recruited

1,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31056427/

CAL02, a novel antitoxin liposomal agent, in severe ... The primary objective of the study was to assess the safety and tolerability of low-dose and high-dose CAL02 in patients with severe community- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05776004

Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in ... This is a placebo-controlled study to evaluate the addition of CAL02 to standard of care in treating hospitalized subjects diagnosed with severe community ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02583373

Study Details | NCT02583373 | Safety, Tolerability, Efficacy ... CAL02 offers a novel therapeutic approach by neutralising bacterial toxins, such as pneumolysin, which recognise specific microdomains on host cell membranes, ...

4. investor.eagleus.com investor.eagleus.com/news-releases/news-release-details/eagle-pharmaceuticals-announces-first-patient-randomized-phase-2

News Details CAL02 is a unique therapeutic agent that works differently from antibiotics, disarming an infectious pathogen's virulence factors to reduce damage and mitigate ...

5. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(18)30805-3/abstract

CAL02, a novel antitoxin liposomal agent, in severe ... Thus, 14 patients received CAL02 (three received low-dose CAL02 and 11 received high-dose CAL02) and five patients received placebo, ...

6. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05776004

Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in ... This is a placebo-controlled study to evaluate the addition of CAL02 to standard of care in treating hospitalized subjects diagnosed with severe community ...