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Study of Trimodulin for Adults Hospitalized with Severe Community-Acquired 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 pneumonia, which is a serious lung infection that people can get outside of a hospital setting. The study is testing a treatment called Trimodulin, which is a solution made from human proteins that help the immune system. This treatment will be compared to a placebo, which looks like the treatment but does not contain the active ingredients. Both Trimodulin and the placebo will be given to patients through an intravenous infusion, meaning they will be administered directly into the bloodstream through a vein.

The purpose of the study is to see if Trimodulin can reduce the number of deaths within 28 days compared to the placebo. Participants in the study are adults who are hospitalized with severe pneumonia. The study will follow these patients over a period of time to monitor their health and recovery. Researchers will look at various outcomes, such as how many patients survive, how their health changes over time, and how long they need to stay in the hospital or intensive care unit.

Throughout the study, doctors will also check for any side effects or reactions to the treatment. The study aims to provide valuable information on whether Trimodulin is a safe and effective treatment for severe pneumonia, potentially offering a new option for patients with this serious condition.

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, written informed consent is required. This means agreeing to participate after understanding the study details.

    Eligibility is confirmed based on criteria such as being an adult hospitalized with severe pneumonia and having certain medical indicators.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the diagnosis of severe community-acquired pneumonia. This includes reviewing medical history and conducting necessary tests.

    Radiological evidence, such as X-rays, is used to confirm active pneumonia.

  3. Step 3

    Treatment initiation

    Treatment with the investigational medication, trimodulin, or a placebo begins within 24 hours after starting mechanical ventilation.

    The medication is administered as an intravenous infusion, which means it is given directly into a vein.

  4. Step 4

    Treatment duration

    The treatment continues as per the study protocol, with regular monitoring of health status and response to the medication.

    The duration of the treatment and frequency of administration are determined by the study guidelines.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, health is closely monitored. This includes checking vital signs, conducting laboratory tests, and assessing overall well-being.

    Regular follow-ups are scheduled to track progress and any changes in health status.

  6. Step 6

    Completion of study

    The study concludes after a specified period, with a final assessment to evaluate the effectiveness and safety of the treatment.

    Participants may be asked to return for additional follow-up visits to monitor long-term outcomes.

Who can join the trial?

8 criteria

  • Written informed consent must be obtained from the subject or their legally authorized representative. This means you or someone legally allowed to make decisions for you must agree to participate after understanding the study.
  • You must be an adult, aged 18 years or older, and can be of any gender.
  • Your C-reactive protein (CRP) level must be 70 mg/L or higher within 24 hours before starting the study treatment. CRP is a substance in your blood that increases when there is inflammation in your body.
  • You must have been diagnosed with active community-acquired pneumonia (CAP) either before being admitted to the hospital or within 48 hours after admission. This is a type of lung infection you get outside of a hospital setting.
  • There must be radiological or other imaging evidence that shows you have active pneumonia. This means there should be images, like X-rays, that confirm the lung infection.
  • You must have acute respiratory failure that requires invasive mechanical ventilation (IMV). This means you need a machine to help you breathe because your lungs are not working well enough on their own.
  • The study treatment must be started between 1 and 24 hours after you begin receiving IMV.
  • You must be receiving standard care treatment for severe community-acquired pneumonia (sCAP) according to the guidelines that apply in your region and globally. This means you should be getting the usual treatment recommended for your condition.

Who cannot join the trial?

7 criteria

  • Patients with **severe community-acquired pneumonia** (sCAP) cannot participate if they have other serious health conditions that might interfere with the study.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible to participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with a history of allergic reactions to the study medication or similar medications cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
  • Patients with certain medical conditions that the study doctors believe would make participation unsafe are not eligible.
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Investigated drugs

Trimodulin (BT588) is a medication being tested in this clinical trial. It is designed to help people who are hospitalized with severe community-acquired pneumonia, which is a serious lung infection. Trimodulin is a type of therapy that aims to support the immune system in fighting the infection. The goal of using trimodulin in this trial is to see if it can reduce the number of deaths within 28 days compared to those who do not receive it. This medication is being studied to determine if it is more effective than not using it at all in treating this severe condition.

What is already known about the treatment

Trimodulin – Trimodulin is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its potential use in treating severe community-acquired pneumonia (sCAP) in hospitalized adults. The main goal of using trimodulin is to reduce the risk of death within 28 days of treatment compared to a placebo. At the molecular level, trimodulin works by modulating the immune system to help the body fight off infections more effectively. It is classified as an immunomodulatory agent, which means it helps regulate the immune response.

Investigated diseases

Severe community-acquired pneumonia (sCAP) – Severe community-acquired pneumonia is a serious lung infection acquired outside of a hospital setting. It begins with symptoms such as cough, fever, chills, and difficulty breathing. As the disease progresses, patients may experience increased respiratory distress and require supplemental oxygen or mechanical ventilation. The infection can lead to inflammation and fluid accumulation in the lungs, impairing oxygen exchange. In severe cases, it can cause systemic effects, impacting other organs and leading to complications like sepsis. The progression of the disease can vary, with some individuals experiencing rapid deterioration.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501352-28-00Protocol code996Estimated enrolment615 patientsSponsorBiotest GmbH & Co. KGaA

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