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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID06774235

Studying Interferon Gamma to Prevent Secondary Infections in Adults with ICU-acquired Immune Suppression

Led by University Hospital, Limoges · Updated on 2025-11-20

326

Participants Needed

23

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of Interferon gamma to prevent secondary infections in patients with sustained immunosuppression acquired in the ICU. This phase 3 randomized trial aims to assess whether Interferon gamma reduces the number of secondary infection episodes at three months, lowers ICU mortality at day 90, shortens ICU and hospital stays, and promotes biological immune restoration by day 10. The study also examines cost-effectiveness and safety of Interferon gamma compared to a placebo. Participants will receive injections of Interferon gamma-1b or a placebo subcutaneously, preferably in the deltoid area or the front thigh. They will be given up to five injections between day 1 and day 9. The placebo consists of a saline solution with the same volume as the active drug. The treatment period lasts for up to nine days. During the trial, participants will be monitored daily until they leave the ICU, with follow-up visits at days 30, 60, and 90. Researchers will assess infection rates, causes of death, length of ICU and hospital stay, antibiotic and antifungal use, immune system recovery, healthcare costs, and any serious adverse reactions. The total participation duration extends to 90 days after treatment begins to evaluate outcomes and safety.

CONDITIONS

Brief Title

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

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