Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression
NCT06774235 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326
Last updated 2025-11-20
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
- DRUG
-
Interferon Gamma 1-b
injection of interferon gamma 1-b
- DRUG
-
Injection of placebo in the same condition of experimental traitment
Sponsors & Collaborators
-
University Hospital, Limoges
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-09
- Primary Completion
- 2028-10-09
- Completion
- 2028-10-09
Countries
- France
Study Locations
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