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

3 1 1

What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Centre Hospitalier Victor Dupouy	Argenteuil	France
Centre Hospitalier William Morey	Chalon Sur Saone	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Centre Hospitalier Le Mans	Le Mans	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Hopital Nord Franche-Comte	Belfort	France
Ccrakc hzmqtvbzblq dl Llzs	Lens	France
Cqhrpm Hysyaqfwiel Dv Bmmxs	Brive La Gaillarde	France
Cqtlsh Hjlsvadzotu Ea Uecmxhuuznjfu Dg Lfnnnmm	Limoges	France
Chogft Hqsrsypnxbe Uitexaodvyxiy Dv Dclhg	Dijon	France
Aaihenutxg Pwrkpnpd Hflxyfvc Dm Meerjilid	Marseille	France
Crijje Hkfyjpevuab Rldoqest Ubtvluplgypcn Dg Tocho	Tours	France
Cqof Dr Nroqc	Vandoeuvre Les Nancy	France
Clxfiw Htrrdwmujkl Rwnvbnzg Ddkousagzrztre	Angers	France
Cplyhm hnsosqyqqjg Mgbjr	Melun	France
Hypbbbql Ubebypwvmqrzis Soicgarhow &bnvpub Herwgpo dk Hfrscqarjof	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.06.2025

Trial locations

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.

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 ID:

2024-516780-93-00

Protocol code:

87RI24_0040

NCT ID:

NCT06774235

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?