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Study on CAL02 and Sodium Chloride for Patients with Severe Community-Acquired Bacterial Pneumonia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as severe community-acquired bacterial pneumonia, which is a serious lung infection that people can get outside of a hospital setting. The study is testing a new treatment called CAL02, which is given through an intravenous infusion, meaning it is delivered directly into the bloodstream. CAL02 contains substances like cholesterol and sphingomyelin (a type of fat found in egg yolks) and is being tested to see if it can help patients recover more quickly when added to the usual care they receive for this type of pneumonia.

The purpose of the study is to evaluate how well CAL02 works and how safe it is compared to a placebo. Participants in the study will receive either CAL02 or a placebo, in addition to the standard treatments they would normally receive for their condition. The study will monitor how quickly patients recover from the pneumonia and any side effects they might experience from the treatment. The treatment period lasts for a maximum of two days, and the study will track the participants' progress over time to gather information on their recovery and any potential side effects.

By participating in this study, researchers hope to learn more about the potential benefits of CAL02 for treating severe community-acquired bacterial pneumonia. The information gathered will help determine if CAL02 can be a safe and effective addition to the current standard of care for this serious lung infection.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the study's purpose and procedures.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, weight, and diagnosis of severe community-acquired bacterial pneumonia (SCABP).

    Your current health status will be evaluated, focusing on specific criteria such as respiratory support needs and any signs of septic shock.

  3. Step 3

    Randomization

    You will be randomly assigned to receive either the study medication CAL02 or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you receive.

  4. Step 4

    Treatment administration

    The study medication or placebo will be administered through an intravenous infusion. This involves receiving the solution directly into your bloodstream via a vein.

    The infusion will be given in addition to the standard care you are already receiving for your condition.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes checking for any side effects or reactions to the infusion.

    The study team will track your progress, focusing on your recovery time and any changes in your condition.

  6. Step 6

    Completion of study

    Once the study period is over, a final assessment will be conducted to evaluate your overall health and recovery.

    You will be informed about the study's findings and your specific treatment group, if applicable.

Who can join the trial?

10 criteria

  • Males or females who are 18 years old or older.
  • Body weight between 40 to 140 kg (88 to 308 pounds).
  • Have a clinical diagnosis of Community-Acquired Bacterial Pneumonia (CABP), diagnosed within 48 hours after being admitted to the hospital.
  • Must have at least one of the following severe conditions:
    • Respiratory failure requiring a machine to help with breathing (invasive mechanical ventilation).
    • Respiratory failure needing non-invasive breathing support, like a mask (e.g., CPAP or BiPAP), with a specific oxygen level measurement (PaO2/FiO2 ratio ≤250 mm Hg), not including home use.
    • Respiratory failure needing high-flow oxygen (more than 40 liters per minute) with a PaO2/FiO2 ratio ≤250 mm Hg.
    • Septic shock requiring medication (vasopressors) to maintain blood pressure, after receiving enough fluids.
    • The severe condition must have started less than 48 hours from the diagnosis of CABP or after discussing with a medical monitor.
    • Need critical care for managing severe community-acquired bacterial pneumonia (SCABP).
    • Must provide written informed consent, or have a legally acceptable representative do so, before any study-specific procedures are done. Standard care assessments may be used for the study.

Who cannot join the trial?

10 criteria

  • Patients with a history of **allergic reactions** to the study medication or its ingredients cannot participate. An allergic reaction is when your body has a bad response to something, like a rash or trouble breathing.
  • Patients who are currently participating in another **clinical trial** are not eligible. A clinical trial is a research study to test new treatments.
  • Patients with **severe liver or kidney disease** cannot join. The liver and kidneys are important organs that help clean your blood and remove waste from your body.
  • Patients who are pregnant or breastfeeding are not allowed to participate. This is to protect the health of the mother and baby.
  • Patients with a history of **substance abuse** in the past year are excluded. Substance abuse means using drugs or alcohol in a way that is harmful to your health.
  • Patients with **uncontrolled diabetes** cannot take part. Diabetes is a condition where your blood sugar levels are too high, and uncontrolled means it is not being managed well with treatment.
  • Patients with **active cancer** are not eligible. Active cancer means the cancer is currently growing or spreading.
  • Patients with **severe heart disease** cannot participate. Heart disease affects how well your heart can pump blood around your body.
  • Patients who have had a **major surgery** in the past month are excluded. Major surgery is a big operation that usually requires a hospital stay.
  • Patients with **severe mental health disorders** that are not well controlled are not eligible. Mental health disorders affect your mood, thinking, and behavior.
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Investigated drugs

CAL02 is a medication being tested in this clinical trial. It is given through an intravenous (IV) line, which means it is delivered directly into the bloodstream. The purpose of CAL02 is to help treat severe community-acquired bacterial pneumonia, a serious lung infection. In this study, CAL02 is used in addition to the usual treatments that patients receive for this condition. The trial aims to see if CAL02 can help patients recover more quickly and to check if it is safe and well-tolerated by those who receive it.

What is already known about the treatment

CAL02 – CAL02 is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials to assess its effectiveness and safety for treating severe community-acquired bacterial pneumonia (SCABP). The main therapeutic indication for CAL02 is to help patients recover from this type of severe pneumonia. At the molecular level, CAL02 works by targeting and neutralizing bacterial toxins, which helps the body fight off the infection more effectively. It is classified pharmacologically as an anti-infective agent.

Investigated diseases

Severe Community-Acquired Bacterial Pneumonia – This disease is a serious lung infection acquired outside of a hospital setting. It is caused by bacteria that invade the lungs, leading to inflammation and fluid accumulation in the air sacs. The disease progresses with symptoms such as high fever, cough with phlegm, difficulty breathing, and chest pain. As the infection worsens, it can lead to severe respiratory distress and the need for hospitalization. The body's immune response to the infection can also cause systemic effects, potentially affecting other organs. Recovery involves the resolution of these symptoms and the clearing of the infection from the lungs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502049-91-00Protocol codeEGL-6535-C-2202Estimated enrolment265 patientsSponsorEagle Pharmaceuticals Inc.

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