RECOMBINANT HUMAN INTERFERON GAMMA 1B for Post-aggressive immunosuppression|Immunosuppression

Inclusion criteria

• {"criterion_text":"- Patient ≥ 18 years old"}
• {"criterion_text":"- SOFA score for first 24 hours post-admission ≥ 6"}
• {"criterion_text":"- Mechanically ventilated at the time of inclusion (non-invasive ventilation (NIV) and high-flow nasal oxygen excluded)"}
• {"criterion_text":"- mHLA-DR< 8,000 AB/C measured between the 5th and 10th day after admission to the intensive care unit"}
• {"criterion_text":"- Patient affiliated to a social security scheme"}
• {"criterion_text":"- Written consent (relative/trusted person)"}

Exclusion criteria

• {"criterion_text":"- Patient with estimated life expectancy of less than 3 months"}
• {"criterion_text":"- People under court protection and protected adults"}
• {"criterion_text":"- Patients with a predicted remaining stay in intensive care < 72 hours"}
• {"criterion_text":"- Patient with pre-existing immunosuppression: solid cancer active or in remission for < 5 years, active hemopathy or in remission for < 5 years, systemic disease (including in the absence of specific treatment), solid organ transplant or marrow allograft patient, patient suffering from a HIV infection"}
• {"criterion_text":"- Patients with an expected prolonged duration of mechanical ventilation: comatose or vegetative patients (admission for severe stroke with Glasgow score < 8, patient resuscitated from an arterial stroke,) patients with tracheotomy for ENT problems, patients suffering from muscular disease (e.g. myopathy), patients on long-term mechanical ventilation"}
• {"criterion_text":"- Pregnant or breast-feeding women"}
• {"criterion_text":"- Patients on immunosuppressive therapy, including long-term corticosteroid therapy (>2.5mg/d prednisone equivalent)"}
• {"criterion_text":"- Patients with severe hepatic or renal insufficiency"}
• {"criterion_text":"- Patient included in another interventional clinical trial"}
• {"criterion_text":"- Contraindication of Imukin (hypersensitivity to interferon gamma-1b or known hypersensitivity to related products, such as another interferon)"}

Primary endpoints

• {"endpoint_text":"- Number of days alive without mechanical ventilation on day 28 after randomization or on discharge from intensive care if this occurs before the 28th day","definition_or_measurement_approach":"Count of days alive and free of mechanical ventilation up to day 28 after randomization or until discharge from intensive care if earlier."}

Secondary endpoints

• {"endpoint_text":"- Evolution and kinetics of mHLA-DR measured at D0, D1, D2, D3, D7 and D28 or at discharge from intensive care if earlier (D0 corresponding to the day of inclusion in the study) between patients treated with recombinant interferon gamma 1-b versus placebo","definition_or_measurement_approach":"Serial mHLA-DR measurements at D0, D1, D2, D3, D7 and D28 or at ICU discharge if earlier; comparison between IFNy and placebo arms."}
• {"endpoint_text":"- Evolution and kinetics of inflammation markers (IL-1, IL-2, IL-6, IL-8, TNFa, etc.) measured in plasma at D0, D3 and D7, or at discharge from intensive care if it occurs before (D0 corresponding to the day of inclusion in the study) between patients treated with recombinant interferon gamma 1-b versus placebo.","definition_or_measurement_approach":"Plasma inflammatory markers measured at D0, D3 and D7 or at ICU discharge if earlier; comparison between arms."}
• {"endpoint_text":"- Mortality rate at D28 and D90 after randomization between patients treated with recombinant interferon gamma 1-b versus placebo","definition_or_measurement_approach":"All-cause mortality assessed at day 28 and day 90 after randomization; comparison between arms."}
• {"endpoint_text":"- The incidence of nosocomial infections during an ICU stay between patients treated with recombinant interferon gamma 1-b versus placebo","definition_or_measurement_approach":"Incidence of nosocomial infections during ICU stay defined according to International Sepsis Forum Consensus Conference criteria; comparison between arms."}
• {"endpoint_text":"- Number of days alive without antibiotic assessed on day 28 after randomization between patients treated with recombinant interferon gamma 1-b versus placebo","definition_or_measurement_approach":"Count of antibiotic-free days up to day 28 after randomization or at ICU discharge if earlier; comparison between arms."}
• {"endpoint_text":"- Number of antibiotic-free days at 28 days after randomization","definition_or_measurement_approach":"Number of days without antibiotics within 28 days after randomization."}
• {"endpoint_text":"- Kinetics of SOFA score assessed at inclusion and during the 7 days following inclusion between patients treated with recombinant interferon gamma 1-b versus placebo","definition_or_measurement_approach":"SOFA score measured at inclusion and daily for 7 days post-inclusion; comparison of kinetics between arms."}
• {"endpoint_text":"- Evolution and kinetics of lymphocyte count measured on D0, D1, D2, D3, D7 and D28 or upon discharge from intensive care if this occurs earlier (D0 corresponding to the day of inclusion in the study) between patients who received recombinant interferon gamma-1b compared with placebo.","definition_or_measurement_approach":"Lymphocyte counts at specified days (D0, D1, D2, D3, D7, D28) or at ICU discharge if earlier; comparison between arms."}
• {"endpoint_text":"- Changes in the transcriptome profile of circulating PBMC using scRNAseq analysis measured at D0, D3 and D7 or at discharge from intensive care if earlier.","definition_or_measurement_approach":"scRNAseq analysis of PBMC transcriptome at D0, D3 and D7 or at ICU discharge if earlier to assess transcriptomic changes."}

France

Earliest CTIS Part Ii Submission Date

21-08-2024

Latest Decision Or Authorization Date

24-10-2025

Processing Time Days

429

Number Of Sites

6

Number Of Participants

170

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France