RECOMBINANT HUMAN INTERFERON GAMMA 1B for Sustained immunosuppression|ICU-acquired sustained immunosuppression

Inclusion criteria

• {"criterion_text":"- Adult patient hospitalized in the ICU for at least 1week"}
• {"criterion_text":"- Expected length of stay in the ICU greater than 10 days at screening"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Immunosuppression defined as an HLA-DR < 8000 Ab/c and a lymphopenia < 1000/mm3 within a 96 hours time window"}
• {"criterion_text":"- Patient or the legal representative giving consent must be able to understand the trial in its entirety"}
• {"criterion_text":"- Patient affiliated to the social security system"}
• {"criterion_text":"- For female participants of childbearing potential, agreement to use dual methods of contraception until Day 90"}
• {"criterion_text":"- For male participants with female partners of childbearing potential, agreement to use barrier method of contraception until Day 90."}

Exclusion criteria

• {"criterion_text":"- Uncontrolled secondary infections ongoing at the time of screening"}
• {"criterion_text":"- Chemotherapy / radiation therapy within the last 6 weeks"}
• {"criterion_text":"- Acute ECG abnormality such as myocardial infarction or any acute life-threatening ECG abnormalities (e.g: ventricular fibrillation, ventricular tachycardia…)"}
• {"criterion_text":"- Apache II ≥ 30"}
• {"criterion_text":"- Mental state rendering the person giving consent incapable of understanding the trial"}
• {"criterion_text":"- Patient deprived of liberty by judicial or administrative decision"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- History of autoimmune disease"}
• {"criterion_text":"- Organ or bone marrow transplant"}
• {"criterion_text":"- History of hematologic malignancy"}
• {"criterion_text":"- History of hepatitis C"}
• {"criterion_text":"- Severe chronic renal failure (eGFR<10 ml/min/1.73m2 CKP-EPI method)"}
• {"criterion_text":"- HIV stage C within the last 12 months"}
• {"criterion_text":"- Hepatic cytolysis with AST/ALT > 5 times ULN (local laboratory)"}
• {"criterion_text":"- Suspected acute pancreatitis with lipase or amylase > 3 times ULN (local laboratory)"}
• {"criterion_text":"- Patient with thrombocytopenia below 50,000/mm3"}
• {"criterion_text":"- Patient with traumatic brain and spinal injury"}
• {"criterion_text":"- Patients under legal protection"}
• {"criterion_text":"- History of or ongoing tuberculosis"}
• {"criterion_text":"- Chronic hepatitis B"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Pregnancy or breast feeding"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Participation in another research clinical trial within 30 days"}

Primary endpoints

• {"endpoint_text":"- Incidence of secondary infection episodes at three months (Day 90) validated by an independent adjudication committee based on the current standardized definitions (CDC surveillance definitions, January 2024)","definition_or_measurement_approach":"Validated by an independent adjudication committee using current standardized definitions (CDC surveillance definitions, January 2024)."}

Secondary endpoints

• {"endpoint_text":"- All-cause ICU mortality and at Day 90","definition_or_measurement_approach":""}
• {"endpoint_text":"- Length of stay in the ICU and in the hospital at Day 90","definition_or_measurement_approach":""}
• {"endpoint_text":"- Antibiotic and antifungal consumption at Day 90","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percentage of biological immune restoration (defined as an HLA-DR > 13 500 Ab/c [Antibodies bound per cell] and an absolute lymphocyte count > 1200 mm3) at Day 10","definition_or_measurement_approach":"Biological immune restoration defined as HLA-DR > 13 500 Ab/c and absolute lymphocyte count > 1200/mm3 measured at Day 10."}
• {"endpoint_text":"- Healthcare costs at Day 90, cost per secondary infection avoided and cost per additional survivor, isolation requirement and antibiotic resistance","definition_or_measurement_approach":""}
• {"endpoint_text":"- Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR) at D90","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

15-01-2025

Latest Decision Or Authorization Date

27-05-2025

Processing Time Days

132

Number Of Sites

23

Number Of Participants

326

Primary sponsor

Full Name

Centre Hospitalier Et Universitaire De Limoges

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France