Study on the Effect of Recombinant Human Interferon Gamma 1b for Patients with Post-Aggressive Immunosuppression in Intensive Care

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for post-aggressive immunosuppression, a condition that can occur in patients who have been in intensive care units (ICUs) and have a weakened immune system after severe illness or injury. The treatment being tested is called recombinant human interferon gamma 1b, which is a type of protein that can help boost the immune system. This study will compare the effects of this treatment to a placebo, which is a substance with no active medication, to see if it can improve the number of days patients are alive without needing a machine to help them breathe.

The purpose of the study is to evaluate whether the treatment can help patients recover better by reducing the time they need mechanical ventilation, which is a machine that helps with breathing. Patients in the study will receive the treatment through an injection under the skin, known as subcutaneous use, over a period of up to three days. The study will monitor patients for 28 days or until they leave the ICU, whichever comes first, to assess the treatment’s effectiveness.

Throughout the study, researchers will also look at various health markers, such as inflammation levels and immune system activity, to understand how the treatment affects the body. The study aims to provide insights into whether recombinant human interferon gamma 1b can help improve outcomes for patients with post-aggressive immunosuppression in ICUs. This research could potentially lead to better treatment options for patients with weakened immune systems following severe illness or injury.

1 inclusion in the study

Eligibility is determined based on specific criteria: age 18 or older, a high severity score (SOFA score of 6 or more within the first 24 hours of admission), mechanical ventilation requirement, and a specific immunosuppression marker (mHLA-DR < 8000 AB/C) measured between the 5th and 10th day after admission to intensive care.

Written consent is required from a relative or trusted person.

2 randomization

Participants are randomly assigned to receive either the treatment or a placebo. This process is double-blind, meaning neither the participants nor the healthcare providers know who receives the treatment or placebo.

3 treatment administration

The treatment involves the subcutaneous administration of recombinant human interferon gamma 1b (IFNy).

The medication is administered as an injectable solution.

4 monitoring and assessments

The primary goal is to evaluate the number of days alive without mechanical ventilation by day 28 or upon discharge from intensive care, whichever comes first.

Secondary assessments include monitoring the evolution of immunosuppression markers (mHLA-DR) and inflammation markers (such as IL-1, IL-2, IL-6, IL-8, TNFa) at specified intervals: day 0 (inclusion day), day 1, day 2, day 3, day 7, and day 28, or at discharge if earlier.

Additional evaluations include mortality rates at day 28 and day 90, incidence of infections acquired in the intensive care unit, and the number of days without antibiotics by day 28.

5 completion of the study

The study is estimated to conclude by October 1, 2027.

The final assessments will be conducted to gather data on the primary and secondary endpoints.

Who Can Join the Study?

Patient must be 18 years old or older.
Patient must have a SOFA score of 6 or higher during the first 24 hours after being admitted. The SOFA score is a way to measure how severe a patient’s condition is.
Patient must be on mechanical ventilation at the time of joining the study. This means they need a machine to help them breathe. Patients using non-invasive ventilation or high-flow nasal oxygen are not included.
Patient must have an mHLA-DR level of less than 8,000 AB/C measured between the 5th and 10th day after being admitted to the intensive care unit. This is a test that helps to understand the patient’s immune system status.
Patient must be affiliated with a social security scheme. This means they should have some form of health insurance or social security coverage.
Patient must provide written consent through a relative or trusted person. This means someone close to them agrees to their participation in the study on their behalf.

Who Cannot Join the Study?

Patients who are not experiencing post-aggressive immunosuppression. This means their immune system is not weakened after a severe illness or treatment.
Patients who do not have a high severity score (SOFA score of less than 6) within the first 24 hours after being admitted to intensive care. The SOFA score is a way to measure how severe a patient’s condition is.
Patients who do not meet the biological criterion of immunosuppression (mHLA-DR of 8000 AB/C or more) measured between days 5 and 10 of their stay in intensive care. This is a specific test to check the level of immune system activity.
Patients who are not admitted to intensive care.
Patients who are not between the specified age ranges for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hopital Beaujon	Clichy	France
Cylxes Hzupkfygdpy Ed Ucesrihmcwftm De Ltixdew	Limoges	France
Ctaz Dr Ngcav	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.07.2024

Trial locations

Investigated drugs:

Interferon Gamma 1-b is a medication used in this trial to help improve the number of days patients can live without needing mechanical ventilation. It is given as an injection under the skin. The trial is testing whether this medication can help patients in intensive care who have a high severity score and signs of weakened immune systems.

Investigated diseases:

Immunosuppression

Post-aggressive immunosuppression – This condition occurs when the immune system becomes less active following a severe physical or psychological stressor, such as surgery, trauma, or critical illness. The body’s ability to fight infections and respond to other immune challenges is reduced, making individuals more susceptible to infections and other complications. The progression of this condition can vary, but it often involves a decrease in immune cell activity and a reduction in the production of important immune signaling molecules. Over time, if the underlying stressor is not resolved, the immunosuppression can persist, leading to prolonged vulnerability to infections. The condition is typically monitored through various biomarkers that indicate immune function, such as mHLA-DR levels.

Trial ID:

2023-506725-11-00

Protocol code:

APHP220672

NCT ID:

NCT06694740

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect of Recombinant Human Interferon Gamma 1b for Patients with Post-Aggressive Immunosuppression in Intensive Care

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?