NCT06774235

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

Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression: a Randomized Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 326 (estimated)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Sustained Immunosuppression

Interventions

Type	Name	Description
DRUG	Interferon Gamma 1-b	injection of interferon gamma 1-b
DRUG	Placebo	Injection of placebo in the same condition of experimental traitment

Timeline

• Start date: 2025-07-09
• Primary completion: 2028-10-09
• Completion: 2028-10-09
• First posted: 2025-01-14
• Last updated: 2025-11-20

Locations

23 sites across 1 country: France