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Study on Preventing Infections in ICU Patients with Interferon Gamma and Sodium Chloride

Verified siteRegistered drugNo placebo
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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 patients who have developed sustained immunosuppression while being treated in the intensive care unit (ICU). This condition means that the body's immune system is weakened and less able to fight off infections. The study is testing a treatment called recombinant human interferon gamma 1b, which is a type of protein that can help boost the immune system. This treatment is being compared to a placebo to see if it can reduce the number of additional infections that patients might get while in the ICU.

The purpose of the study is to find out if using recombinant human interferon gamma 1b can lower the chances of getting new infections over a period of three months. Patients in the study will receive the treatment through a subcutaneous injection, which means it is given under the skin. The study will last for about three months, during which the health of the patients will be closely monitored to see if the treatment is effective and safe.

In addition to looking at the number of new infections, the study will also track other important outcomes, such as the overall survival of patients in the ICU, the length of their stay in the hospital, and any side effects they might experience. The study aims to provide valuable information on whether this treatment can help improve the health and recovery of patients with sustained immunosuppression in the ICU.

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 trial

    Upon joining the trial, you will be informed about the study's purpose, which is to evaluate the benefit of a standardized immunotherapy with interferon gamma on preventing secondary infections in patients with sustained immune suppression in the intensive care unit (ICU).

    You will be required to provide consent, either personally or through a legal representative, confirming your understanding of the trial and your willingness to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying that you have been in the ICU for at least one week and are expected to stay for more than ten days.

    Your medical condition will be evaluated, including checking for multiple organ failure and specific immune system markers.

  3. Step 3

    Treatment administration

    If eligible, you will receive the treatment through a subcutaneous injection, which means the medication is injected under the skin.

    The treatment involves the use of IMUKIN, which contains recombinant human interferon gamma 1b. The dosage is 2 million international units (UI), equivalent to 0.1 mg, administered as a solution for injection.

    The frequency and duration of the treatment will be determined by the study protocol, and you will be informed about the schedule.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, your health will be closely monitored to assess the incidence of secondary infections and any potential side effects.

    Regular check-ups will be conducted to evaluate your immune system's response and overall health status.

  5. Step 5

    Completion of the trial

    The trial will conclude after three months (Day 90) from the start of your participation.

    At the end of the trial, a final assessment will be conducted to evaluate the outcomes, including any changes in your health condition and the effectiveness of the treatment.

Who can join the trial?

8 criteria

  • Adult patient who has been in the Intensive Care Unit (ICU) for at least 1 week.
  • Expected to stay in the ICU for more than 10 days at the time of screening.
  • Has experienced at least one episode of multiple organ failure. This means that the patient has a SOFA score of 6 or more. The SOFA score is a way to measure how well the organs in the body are working, excluding the breathing part if it is related to a brain problem, during the first week in the ICU.
  • Has immunosuppression, which means the immune system is not working well. This is defined as having an HLA-DR level of less than 8000 Ab/c and a lymphopenia of less than 1000/mm3 within a 96-hour period. HLA-DR is a marker on white blood cells, and lymphopenia means having a low number of lymphocytes, which are a type of white blood cell.
  • The patient or their legal representative must be able to understand the trial completely and give consent to participate.
  • The patient must be affiliated with the social security system.
  • For female participants who can have children, they must agree to use two methods of birth control until Day 90 of the study.
  • For male participants with female partners who can have children, they must agree to use a barrier method of birth control until Day 90 of the study.

Who cannot join the trial?

4 criteria

  • Patients who are not experiencing sustained immunosuppression cannot participate. Sustained immunosuppression means the immune system is weakened for a long time, making it harder to fight infections.
  • Patients who are not in the Intensive Care Unit (ICU) cannot participate. The ICU is a special hospital department for people who need intensive medical care.
  • Patients who are not between the ages of 18 and 65 cannot participate.
  • Patients who are not able to give informed consent cannot participate. Informed consent means understanding the study and agreeing to take part.
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Investigated drugs

Interferon Gamma is a type of protein that the body naturally produces to help fight infections and boost the immune system. In this clinical trial, it is used as a therapy to help prevent secondary infections in patients who are in the intensive care unit (ICU) and have weakened immune systems. The goal is to see if giving patients this protein can help strengthen their immune response and reduce the number of infections they get while in the ICU.

What is already known about the treatment

Interferon gamma – Interferon gamma is administered through injection, typically under the skin or into a muscle. It is currently being studied in clinical trials for its potential to prevent secondary infections in patients in intensive care units (ICUs) who have weakened immune systems. The main therapeutic use being explored is to boost the immune response in these patients to reduce the risk of infections. At the molecular level, interferon gamma works by activating immune cells and enhancing their ability to fight off infections. It is classified as an immunomodulatory agent, which means it helps regulate or normalize the immune system.

Investigated diseases

Sustained Immunosuppression – Sustained immunosuppression is a condition where the immune system remains in a weakened state over an extended period. This can occur due to various factors, including medical treatments like chemotherapy, organ transplantation, or diseases that affect immune function. In this state, the body’s ability to fight off infections and diseases is significantly reduced. As a result, individuals with sustained immunosuppression are more susceptible to infections and may experience them more frequently. The condition can lead to an increased risk of secondary infections, especially in environments like intensive care units. Over time, the persistent lack of immune response can complicate recovery from illnesses and increase vulnerability to new infections.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516780-93-00Protocol code87RI24_0040Estimated enrolment326 patientsSponsorCentre Hospitalier Universitaire De Limoges

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).