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MD","antoine.guillon@univ-tours.fr",{"name":429,"role":98,"phone":44,"phoneExt":44,"email":44},{"type":433,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100575588",false,"NCT06774235","Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression","Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression: a Randomized Trial","PLATINIUM","Inclusion Criteria:\n\n* Adult patient hospitalized in the ICU for at least 1 week\n* Expected length of stay in the ICU greater than 10 days at screening\n* 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\n* Immunosuppression defined as an mHLA-DR \\\u003C 8000 Ab\u002Fc and a lymphopenia \\\u003C 1000\u002Fmm3 within a 96 hours time window\n* Patient or the legal representative giving consent must be able to understand the trial in its entirety\n* Patient affiliated to the social security system\n* For female participants of childbearing potential, agreement to use dual methods of contraception until Day 90\n* For male participants with female partners of childbearing potential, agreement to use barrier method of contraception until Day 90.\n\nExclusion Criteria:\n\n* Uncontrolled secondary infections ongoing at the time of screening\n* Participation in another research clinical trial within 30 days\n* Chemotherapy \u002F radiation therapy within the last 6 weeks\n* Apache II ≥ 30 at screening\n* History of autoimmune disease\n* Organ or bone marrow transplant\n* History of hematologic malignancy\n* History of hepatitis C\n* HIV stage C within the last 12 months\n* Patients under legal protection\n* History of or ongoing tuberculosis\n* Chronic hepatitis B\n* Patients receiving immunosuppressive medications including patient receiving a steroid dose greater than 1mg\u002Fkg\u002Fday of prednisone equivalent for more than 1 week and patient that have been on corticosteroid for more than 3 months\n* Patient with thrombocytopenia below 50,000\u002Fmm3\n* Patient with traumatic brain and spinal injury\n* Pregnancy or breast feeding\n* Subjects with a history hypersensitivity to interferon gamma or excipient (Mannitol, Sodium succinate dibasic hexahydrate, Succinic acid, polysorbate 20), known latex hypersensitivity or other interferon\n* Hepatic cytolysis with AST\u002FALT \\> 5 times ULN (local laboratory)\n* Suspected acute pancreatitis with lipase or amylase \\> 3 times ULN (local laboratory)\n* Severe chronic renal failure (eGFR\\\u003C10 ml\u002Fmin\u002F1.73m2 CKP-EPI method)\n* Acute ECG abnormality such as myocardial infarction or any acute life-threatening ECG abnormalities (e.g: ventricular fibrillation, ventricular tachycardia…)\n* Mental state rendering the person giving consent incapable of understanding the trial\n* Patient deprived of liberty by judicial or administrative decision\n* Patient being the investigator, or any member of the team or relative of the investigator directly involved in the trial, including assistant doctors, pharmacists, nurses, trial coordinators","ALL","18 Years",{"count":444,"type":445},326,"ESTIMATED","INTERVENTIONAL",[448],"PHASE3","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:\n\nDoes Interferon-gamma:\n\n* reduces the Incidence of secondary infection episodes at three months\n* reduces the ICU mortality and at Day 90\n* reduces the ICU and hospital length of stay\n* induces Biological immune restoration at Day 10\n* has cost-consequence and cost-effectiveness\n\nResearchers 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 .\n\nParticipants will:\n\n* Take Interferon-Gamma or a placebo for a maximum of 5 times between day 1 and day 9\n* be monitored evety day until their ICU discharge and at day 30, 60 and 90",[451],"Sustained Immunosuppression",[453,454,455,456],"ICU","Immuno-restauration","Secondary infections","Prevention","2025-11-19",{"date":459,"type":460},"2025-11-20","ACTUAL",{"date":462,"type":460},"2025-07-09",{"date":464,"type":445},"2028-10-09",{"name":5,"class":6},23]