The goal of this clinical trial is to demonstrate the benefit of a standardized immunotherapy (Interferon gamma) on the incidence of secondary infections. . It will also learn about the safety of Interferon-gamma. The main questions it aims to answer are:
Does Interferon-gamma:
* reduces the Incidence of secondary infection episodes at three months * reduces the ICU mortality and at Day 90 * reduces the ICU and hospital length of stay * induces Biological immune restoration at Day 10 * has cost-consequence and cost-effectiveness
Researchers will compare Interferon-gamma to a placebo (a look-alike substance that contains no drug) to see if Interferon-gamma works to treat sustained immunosuppression .
Participants will:
* Take Interferon-Gamma or a placebo for a maximum of 5 times between day 1 and day 9 * be monitored evety day until their ICU discharge and at day 30, 60 and 90
Adult patient hospitalized in the ICU for at least 1 week
Expected length of stay in the ICU greater than 10 days at screening
At least 1 episode of multiple organ failure, defined as a SOFA ≥ 6 (excluding the respiratory component when related to a neurological failure), during the first 1 week of ICU hospitalization
Immunosuppression defined as an mHLA-DR < 8000 Ab/c and a lymphopenia < 1000/mm3 within a 96 hours time window
Uncontrolled secondary infections ongoing at the time of screening
Participation in another research clinical trial within 30 days
Chemotherapy / radiation therapy within the last 6 weeks
Apache II ≥ 30 at screening
Parallel
Interferon Gamma 1-b
Druginjection of interferon gamma 1-b
Placebo
DrugInjection of placebo in the same condition of experimental traitment
Incidence of secondary infection episodes
Number of episodes divided by the follow-up length, in days, validated by an independent adjudication committee based on the current definitions.
Cause of mortality of participant
All-cause ICU mortality and at Day 90
Length of stay in the ICU and in the hospital
Number of days spent in the ICU and in the hospital at Day 90
Antibiotic consumption
Name of antibiotics taken at Day 90
Biological immune restoration
Percentage of biological immune restoration (defined as an HLA-DR \> 13 500 Ab/c \[Antibodies bound per cell\] and an absolute lymphocyte count \> 1200 mm3) at Day 10
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