Human Recombinant Interferon Gamma in the Treatment of Ventilator-acquired Pneumonia in ICU Patients (IGNORANT)
Pneumonia, Ventilator-Associated
About this trial
This is an interventional treatment trial for Pneumonia, Ventilator-Associated focused on measuring Critical Illness, Interferon-gamma, Immunodepression, Sepsis, Trauma, Monocyte HLA-DR, immunostimulation
Eligibility Criteria
Inclusion Criteria: adult patients hospitalized in intensive care unit under mechanical ventilation for more than 5 days having a first episode of VAP (with a Clinical Pulmonary Infectious Score (CPIS score) >6) treated with antibiotics for less than 24 hours with monocyte HLA-DR < 8000 AB/C Exclusion Criteria: Noradrenaline > 0.25 mcg/kg/min Immunosuppression, defined by: solid tumor with chemotherapy in the last 3 months progressive metastatic disease hematological disease solid organ transplantation HIV infection (AIDS stage or not) corticosteroid therapy at any dose for more than 3 months ≥ 1 mg/kg of Prednisone equivalent for more than 7 days immunosuppressive therapy Head and/or cervical spine trauma Cardiocirculatory arrest Burn patient Cirrhosis with Child B or C score Infection with Aspergillus spp. Refusal to participate Patient participating in another interventional research in progress or including an exclusion period still in progress at pre-inclusion (excluding interventional research of 2° not interfering with the endpoints of the study according to the judgment of the principal investigator) Lack of social coverage Patient under curatorship or guardianship Pregnant or breastfeeding women Patient admitted to intensive care for SARS-Cov2 pneumonia Known allergy to latex Hypersensitivity to the active substance (interferon gamma-1b) or known hypersensitivity to related products, such as another interferon, or to any of the following excipients: Mannitol, Disodium succinate hexahydrate, Succinic acid, polysorbate 20 Existence of chronic heart disease with FeVG<45% Major hepatic impairment (total bilirubin>60 mg/L or 102 mcmol/L, equivalent to 3 SOFA points) thrombocytopenia <50000/mm3 (equivalent to 3 SOFA points) AST and/or ALT > 5N Lipase > 3N Severe chronic renal failure (creatinine clearance MDRD< 10 ml/min/1.73m2) Thrombocytopenia <50,000/mm3 (equivalent to 3 SOFA points)
Sites / Locations
- Service civilo-militaire d'Anesthésie-Réanimation et Médecine PériopératoireRecruiting
- Service de reanimation chirurgicale Hopital Croix-Rousse
- Service de reanimation médicale hôpital de la Croix-Rousse
- Service d'anesthésie-réanimation, unité de réanimation chirurgicale Picard
- Médecine intensive- Réanimation
- Service d'Anesthésie-réanimation-médecine intensive Hôpital Lyon Sud
- Département Anesthésie-Réanimation
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Interferon gamma treatment
Placebo
Interferon gamma treatment (100 micrograms /day during 5 days)
The comparator drug (placebo) is an injectable solution of sodium chloride 0.9%