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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
326
injection of interferon gamma 1-b
Injection of placebo in the same condition of experimental traitment
Angers university hospial
Angers, France
RECRUITINGArgenteuil hospital
Argenteuil, France
RECRUITINGFranche-comté north Hospital
Belfort, France
RECRUITINGBrive Hospital
Brive-la-Gaillarde, France
RECRUITINGChalon sur saone Hospital
Chalon-sur-Saône, France
RECRUITINGDijon University Hospital
Dijon, France
RECRUITINGAPHP - Raymond Poincaré
Garches, France
RECRUITINGVersailles Hospital
Le Chesnay, France
RECRUITINGLe mans Hospital
Le Mans, France
RECRUITINGCH de Lens
Lens, France
RECRUITING...and 13 more locations
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.
Time frame: Day 90
Cause of mortality of participant
All-cause ICU mortality and at Day 90
Time frame: 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
Time frame: Day 90
Antibiotic consumption
Name of antibiotics taken at Day 90
Time frame: 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
Time frame: Day 10
Healthcare costs
Healthcare costs at Day 90, cost per secondary infection avoided and cost per additional survivor, isolation requirement and antibiotic resistance
Time frame: Day 90
Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR)
Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR) at D90 according to sponsor causality assessment
Time frame: Day 90
Antifungal consumption
Name of antifungals taken at Day 90
Time frame: Day 90
Antifungal consumption
Dosage of antifungals taken at Day 90
Time frame: Day 90
Antifungal consumption
Duration of antifungals taken at Day 90
Time frame: Day 90
Antibiotic consumption
Dosage of antibiotics taken at Day 90
Time frame: Day 90
Antibiotic consumption
Duration of antibiotics taken at Day 90
Time frame: Day 90
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