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Study on the Effectiveness and Safety of IgM-Enriched Immunoglobulin Therapy for Patients with Septic Shock

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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 the effectiveness and safety of a treatment for septic shock, a serious condition that occurs when an infection leads to dangerously low blood pressure and organ failure. The treatment being tested is called Pentaglobin, which is a solution containing immunoglobulins, specifically immunoglobulin A, immunoglobulin G, and immunoglobulin M. These are proteins derived from blood that help the immune system fight infections.

The purpose of the study is to determine if a personalized dose of this treatment, based on the levels of immunoglobulin M in the blood, is more effective in reducing the risk of death in patients with septic shock compared to a standard dose. Participants in the study will receive either the personalized dose or the standard dose of Pentaglobin. The study will monitor the participants over a period of time to assess the outcomes, including survival rates and any new organ dysfunctions.

The study is designed to be adaptive, meaning it can adjust based on the results as it progresses. It is conducted in a way that neither the participants nor the researchers know which dose each participant is receiving, ensuring unbiased results. The main goal is to see if the personalized dosing approach can improve survival rates at 28 days after treatment begins. The study will also look at other factors, such as recovery and any side effects related to the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting specific criteria: age over 18, septic shock occurring within the last 24 hours, and certain blood test results.

    Septic shock is a serious condition where blood pressure drops dangerously low due to an infection.

  2. Step 2

    Treatment allocation

    Participants are randomly assigned to one of two groups: one receiving a personalized dose of IgM-enriched immunoglobulin and the other receiving a standard dose.

    The treatment is administered intravenously, meaning it is given directly into a vein.

  3. Step 3

    Treatment administration

    The medication used is called Pentaglobin, a solution for infusion containing immunoglobulins, which are proteins that help fight infections.

    The dosage and frequency depend on the group assignment and individual blood test results.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for any changes in health, including new organ dysfunctions and overall recovery progress.

    The primary goal is to assess mortality rates at 28 days after treatment begins.

  5. Step 5

    Study completion

    The study aims to conclude by February 19, 2025, with final assessments including mortality at hospital discharge and other health outcomes.

    Participants' health is evaluated at various points, including 7, 28, and 90 days after treatment, or upon hospital discharge.

Who can join the trial?

5 criteria

  • Must be older than 18 years.
  • Must have experienced septic shock within the last 24 hours. Septic shock is a serious condition where the blood pressure drops to a dangerously low level due to an infection.
  • Septic shock is identified by needing medication to keep blood pressure at 65 mm Hg or higher and having a blood lactate level greater than 2 mmol/L (which is more than 18 mg/dL). This should happen without low blood volume in patients with sepsis.
  • Sepsis is a severe condition where the body's response to infection causes organ dysfunction. It is identified by a sudden change in the SOFA score, which is a measure of organ function, by 2 or more points.
  • Must have IgM-titers, which are a type of antibody level, less than 60 mg/dL (or less than 20% of the lower threshold value of the local laboratory) within 24 hours from the occurrence of shock.

Who cannot join the trial?

3 criteria

  • Patients who are not experiencing septic shock cannot participate. Septic shock is a serious condition that happens when an infection leads to dangerously low blood pressure.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are unable to understand the study, cannot participate.
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Investigated drugs

IgM-enriched immunoglobulin therapy: This therapy involves using immunoglobulins that are enriched with IgM, a type of antibody. The treatment is designed to support the immune system in patients with septic shock. In this trial, the therapy is being tested in two different ways: one group receives a personalized dose based on their serum IgM levels, while the other group receives a standard dose. The goal is to determine which dosing method is more effective in reducing mortality in patients with septic shock.

What is already known about the treatment

IgM-enriched Immunoglobulin – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating septic shock. It is an adjunctive therapy, meaning it is used in addition to standard treatments, with the aim of reducing mortality in patients. The medication works by enhancing the immune response through the presence of IgM antibodies, which help to neutralize pathogens and clear infections. It is classified as an immunoglobulin therapy, specifically enriched with IgM, and is being evaluated for its potential benefits over standard dosing methods.

Investigated diseases

Septic shock – Septic shock is a severe and potentially life-threatening condition that occurs when an infection leads to dangerously low blood pressure and abnormalities in cellular metabolism. It is a subset of sepsis, which is the body's extreme response to an infection. During septic shock, the body's organs and tissues may not receive enough oxygen and nutrients, leading to organ dysfunction. The condition progresses rapidly and requires immediate medical attention to prevent further complications. It is characterized by symptoms such as confusion, shortness of breath, high heart rate, and fever or hypothermia. The progression of septic shock can lead to multiple organ failure if not managed promptly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518096-57-00Estimated enrolment356 patientsSponsorAzienda Ospedaliero Universitaria Di Modena

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