Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT06694740

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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