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Prevention of secondary infections by interferon gamma in ICU-acquired sustained immune-suppression: a randomized trial
EU CTIS ID: 2024-516780-93-00
What this study is testing
To demonstrate the benefit of a standardized immunotherapy with IFN-γ versus placebo on the incidence of secondary infections at three months (Day 90) in ICU patients with documented sustained immunosuppression.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patient hospitalized in the ICU for at least 1week at the time of randomization
- 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 weeks of ICU hospitalization
- Immunosuppression defined as an HLA-DR < 8000 Ab/c and at least a lymphocyte count < 1000/mm3 within a 96 hours time window. A single lymphocyte count within the 96-hour window is needed to assess patient eligibility. However, if additional WBC is performed during this period, and lymphocytes have raised up to 1100/mm3, the patient remains eligible, as long as mHLA-DR is <8000 Ab/c
- Patient or the legal representative giving consent must be able to understand the trial in its entirety
- Patient affiliated to the social security system
You likely can't join if
- Uncontrolled secondary infections ongoing at the time of screening
- Chemotherapy / radiation therapy within the last 6 weeks
- Acute ECG abnormality such as myocardial infarction or any acute life-threatening ECG abnormalities (e.g: ventricular fibrillation, ventricular tachycardia…)
- Apache II ≥ 30
- Mental state rendering the person giving consent incapable of understanding the trial
- Patient deprived of liberty by judicial or administrative decision
See the full eligibility criteria
- Adult patient hospitalized in the ICU for at least 1week at the time of randomization
- 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 weeks of ICU hospitalization
- Immunosuppression defined as an HLA-DR < 8000 Ab/c and at least a lymphocyte count < 1000/mm3 within a 96 hours time window. A single lymphocyte count within the 96-hour window is needed to assess patient eligibility. However, if additional WBC is performed during this period, and lymphocytes have raised up to 1100/mm3, the patient remains eligible, as long as mHLA-DR is <8000 Ab/c
- 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.
- Uncontrolled secondary infections ongoing at the time of screening
- Chemotherapy / radiation therapy within the last 6 weeks
- Acute ECG abnormality such as myocardial infarction or any acute life-threatening ECG abnormalities (e.g: ventricular fibrillation, ventricular tachycardia…)
- Apache II ≥ 30
- 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
- History of autoimmune disease
- Organ or bone marrow transplant
- History of hematologic malignancy
- History of hepatitis C
- Severe chronic renal failure (eGFR<10 ml/min/1.73m2 CKP-EPI method)
- HIV stage C within the last 12 months
- Hepatic cytolysis with AST/ALT > 5 times ULN (local laboratory)
- Suspected acute pancreatitis with lipase or amylase > 3 times ULN (local laboratory)
- Patient with thrombocytopenia below 50,000/mm3
- Patient with traumatic brain and spinal injury
- 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 ( see appendix 1)
- 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
- Participation in another research clinical trial within 30 days
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.