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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

Effect of Interferon Gamma as a Treatment for Post-aggressive Immunosuppression in Intensive Care Units, a Randomized Bayesian Double-blind Controlled Trial Versus Placebo

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The vast majority of serious clinical situations leading to intensive care (septic shock, polytrauma, acute cerebral aggression, major surgery) are characterized by significant systemic inflammation. Recently, the existence of a common immune response pattern to acute aggression has been demonstrated, and with it the existence of a phenomenon known as post-aggressive immunosuppression (PAIS).

Who May Be Eligible (Plain English)

Who May Qualify: - Patient ≥ 18 years old - SOFA score for first 24 hours post-admission ≥ 6 - Mechanically ventilated at the time of inclusion (non-invasive ventilation (NIV) and high-flow nasal oxygen excluded) - mHLA-DR\< 8,000 AB/C measured between the 5th and 10th day after admission to the intensive care unit - Patient affiliated to a social security scheme - Written consent (relative/trusted person) Who Should NOT Join This Trial: - Patient with estimated life expectancy of less than 3 months - Patients with a predicted remaining stay in intensive care \< 72 hours - 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 - 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 - Pregnant or breast-feeding women - Contraindication of Imukin (hypersensitivity to interferon gamma-1b or known hypersensitivity to related products, such as another interferon) - Patients on immunosuppressive therapy, including long-term corticosteroid therapy (\>2.5mg/d prednisone equivalent) - Patients with severe hepatic or renal insufficiency - Patient included in another interventional clinical trial - People under court protection and protected adults Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patient ≥ 18 years old * SOFA score for first 24 hours post-admission ≥ 6 * Mechanically ventilated at the time of inclusion (non-invasive ventilation (NIV) and high-flow nasal oxygen excluded) * mHLA-DR\< 8,000 AB/C measured between the 5th and 10th day after admission to the intensive care unit * Patient affiliated to a social security scheme * Written consent (relative/trusted person) Exclusion Criteria: * Patient with estimated life expectancy of less than 3 months * Patients with a predicted remaining stay in intensive care \< 72 hours * 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 * 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 * Pregnant or breast-feeding women * Contraindication of Imukin (hypersensitivity to interferon gamma-1b or known hypersensitivity to related products, such as another interferon) * Patients on immunosuppressive therapy, including long-term corticosteroid therapy (\>2.5mg/d prednisone equivalent) * Patients with severe hepatic or renal insufficiency * Patient included in another interventional clinical trial * People under court protection and protected adults

Treatments Being Tested

DRUG

Interferon Gamma 1-b

interferon gamma-1b 2 X 106 IU, injectable solution. Subcutaneous injection every 24 hours for 3 consecutive days (3 total injections)

DRUG

Placebo

Patients randomized to the placebo arm will receive saline injectable solution. Subcutaneous injection every 24 hours for 3 consecutive days (3 total injections)

Locations (2)

Dr de Roquetaillade
Paris, France
Pr Dépret
Paris, France