About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Interferon Gamma 1-b
- Placebo