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RecruitingPhase 2Phase 3NCT06694740

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

170 participants

Start Date

Jan 12, 2026

Study Type

INTERVENTIONAL

Conditions

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

Summary

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria10

  • 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
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Interventions

DRUGInterferon Gamma 1-b

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

DRUGPlacebo

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

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NCT06694740