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

NCT06694740

RecruitingPhase 2, Phase 3

Sponsor: Assistance Publique - Hôpitaux de Paris

Conditions: Post-aggressive Immunosuppression, Adult Patients Admitted to Intensive Care With Initial Severity (SOFA of the First 24 Hours Post-admission ≥ 6, Adult Under Mechanical Ventilation, and Presenting an mHLA-DR Less Than 8,000AB/C

Interventions: Interferon Gamma 1-b, Placebo

Countries: France

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (2)

Paris, France
Paris, France