drugset / Trial / NCT06774235

Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression

NCT06774235

Phase 3 Recruiting 326 enrolled University Hospital, Limoges
RandomizedParallel-groupTriple-blindTreatment

Summary

The goal of this clinical trial is to demonstrate the benefit of a standardized immunotherapy (Interferon gamma) on the incidence of secondary infections. . It will also learn about the safety of Interferon-gamma. The main questions it aims to answer are: Does Interferon-gamma: * reduces the Incidence of secondary infection episodes at three months * reduces the ICU mortality and at Day 90 * reduces the ICU and hospital length of stay * induces Biological immune restoration at Day 10 * has cost-consequence and cost-effectiveness Researchers will compare Interferon-gamma to a placebo (a look-alike substance that contains no drug) to see if Interferon-gamma works to treat sustained immunosuppression . Participants will: * Take Interferon-Gamma or a placebo for a maximum of 5 times between day 1 and day 9 * be monitored evety day until their ICU discharge and at day 30, 60 and 90

Timeline

Start
2025-07-09
Primary completion
2028-10-09
Completion
2028-10-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Interferon gamma-1b Protein / enzyme biologic Subcutaneous