Actively Recruiting
Effect of Interferon Gamma as a Treatment for Post-aggressive Immunosuppression in Intensive Care Units, a Randomized Bayesian Double-blind Controlled Trial Versus Placebo
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-22
170
Participants Needed
2
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Effect of Interferon Gamma as a Treatment for Post-aggressive Immunosuppression in Intensive Care Units, a Randomized Bayesian Double-blind Controlled Trial Versus Placebo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years or older
- SOFA score of 6 or higher during the first 24 hours after ICU admission
- Currently on mechanical ventilation (excluding non-invasive ventilation and high-flow nasal oxygen)
- mHLA-DR expression less than 8,000 AB/C measured between days 5 and 10 after ICU admission
- Affiliated with a social security scheme
- Written consent provided by a relative or trusted person
You will not qualify if you...
- Estimated life expectancy less than 3 months
- Expected ICU stay shorter than 72 hours
- Pre-existing immunosuppression, including active or recent (less than 5 years) solid cancer or blood diseases, systemic diseases, organ transplant, bone marrow transplant, or HIV infection
- Expected prolonged mechanical ventilation due to coma, vegetative state, tracheotomy for ENT problems, muscular diseases, or long-term ventilation
- Pregnant or breastfeeding women
- Allergic to interferon gamma-1b or similar products
- Receiving immunosuppressive therapy, including long-term corticosteroids over 2.5 mg/day prednisone equivalent
- Severe liver or kidney failure
- Currently enrolled in another interventional clinical trial
- Under court protection or legally protected adult
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Dr de Roquetaillade
Paris, France
Actively Recruiting
2
Pr Dépret
Paris, France
Actively Recruiting
Research Team
C
Charles De ROQUETAILLADE, MD
CONTACT
B
Benjamin CHOUSTERMAN, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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