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Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression

RecruitingPhase 3Ages 18 Years - anyAllUniversity Hospital, Limoges
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Patient or the legal representative giving consent must be able to understand the trial in its entirety * Patient affiliated to the social security system * For female participants of childbearing potential, agreement to use dual methods of contraception until Day 90 * For male participants with female partners of childbearing potential, agreement to use barrier method of contraception until Day 90. Exclusion Criteria: * 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 * History of autoimmune disease * Organ or bone marrow transplant * History of hematologic malignancy * History of hepatitis C * HIV stage C within the last 12 months * Patients under legal protection * History of or ongoing tuberculosis * Chronic hepatitis B * Patients receiving immunosuppressive medications including patient receiving a steroid dose greater than 1mg/kg/day of prednisone equivalent for more than 1 week and patient that have been on corticosteroid for more than 3 months * Patient with thrombocytopenia below 50,000/mm3 * Patient with traumatic brain and spinal injury * Pregnancy or breast feeding * 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 * Hepatic cytolysis with AST/ALT \> 5 times ULN (local laboratory) * Suspected acute pancreatitis with lipase or amylase \> 3 times ULN (local laboratory) * Severe chronic renal failure (eGFR\<10 ml/min/1.73m2 CKP-EPI method) * Acute ECG abnormality such as myocardial infarction or any acute life-threatening ECG abnormalities (e.g: ventricular fibrillation, ventricular tachycardia…) * Mental state rendering the person giving consent incapable of understanding the trial * Patient deprived of liberty by judicial or administrative decision * 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
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What it tests

  • Interferon Gamma 1-b
  • Placebo
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Where

23 sites
Angers university hospial
Angers, France
Argenteuil hospital
Argenteuil, France
Franche-comté north Hospital
Belfort, France
Brive Hospital
Brive-la-Gaillarde, France
Chalon sur saone Hospital
Chalon-sur-Saône, France
Dijon University Hospital
Dijon, France
APHP - Raymond Poincaré
Garches, France
Versailles Hospital
Le Chesnay, France

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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