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

NCT06694740 Phase 2/Phase 3 RECRUITING

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).

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 2/Phase 3
Status	RECRUITING
Enrolment	170
Start date	2026-01-12
Completion	2028-04

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

Primary outcomes

• number of days alive without mechanical ventilation — on Day 28 after drug administration
  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

Countries

France