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
University Hospital, Limoges
326 participants
Jul 9, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria8
- 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 Criteria24
- 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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Interventions
injection of interferon gamma 1-b
Injection of placebo in the same condition of experimental traitment
Locations(23)
View Full Details on ClinicalTrials.gov
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NCT06774235