Effect of Interferon Gamma as a Treatment for Post-aggressive Immunosuppression in Intensive Care Units, a Randomized Bayesian Double-blind Controlled Trial Versus Placebo

Recruiting Phase 2 Phase 3 Interventional Study
Post-aggressive Immunosuppression Adult Patients Admitted to Intensive Care With Initial Severity (SOFA of the First 24 Hours Post-admission ≥ 6 Adult Under Mechanical Ventilation, and Presenting an mHLA-DR Less Than 8,000AB/C
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
170 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patient ≥ 18 years old * SOFA score for first 24 hours post-admission ≥ 6 * Mechanically ventilated at the time of inclusion (non-invasive ventilation (NIV) and high-flow nasal oxygen excluded) * mHLA-DR\< 8,000 AB/C measured between the 5th and 10th day after admission to the…
Contacts

Charles De ROQUETAILLADE, MD

01 49 95 55 68

charles.de-roquetaillade@aphp.fr

CONTACT

Benjamin CHOUSTERMAN, Professor

01 49 95 85 18

benjamin.chousterman@aphp.fr

CONTACT