Human recombinant interferon gamma in the treatment of ventilator-acquired pneumonia in ICU patients. IGNORANT study

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 132

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 CPIS score >6), treated with antibiotics for less than 24 hours, with monocyte HLA-DR < 8000 AB/C, written informed consent signed by the trusted support person, Affiliation to a social security scheme

Exclusion Criteria

Noradrénaline > 0.25 mcg/kg/min, thrombocytopenia <50000/mm3 (equivalent to 3 SOFA points), 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), AST and/or ALT > 5N, Lack of social coverage, Lipase > 3N, Severe chronic renal failure (creatinine clearance MDRD< 10 ml/min/1.73m2), 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 other interferons, 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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of recombinant human interferon gamma in reducing the duration of mechanical ventilation during the first episode of VAP in a population of patients treated in intensive care in addition to antibiotic treatment and having an mHLA-DR < 8000AB/C.;Secondary Objective: mortality, microbiological healing, The occurrence of another episode of VAP before extubation, Length of stay in intensive care unit, length of stay at hospital, prevention of infectious recurrences, the host's immune response, Evaluation of the economic efficiency of the administration of IFN-?;Primary end point(s): mechanical ventilation-free days (VFD) from extubation through D28. A beneficial effect of using recombinant human interferon gamma-1b would be a statistically significant increase in VFD in patients receiving study drug in this setting compared to the group receiving placebo.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):All-cause mortality in intensive care at D28;Secondary end point(s):Bacteriological samples become negative;Secondary end point(s):The occurrence of another episode of VAP before extubation;Secondary end point(s):length of stay in intensive care unit;Secondary end point(s):length of stay at hospital;Secondary end point(s):The evolution of monocytic HLA-DR kinetics;Secondary end point(s):the evolution of leukocytes kinetics;Secondary end point(s):Assessment of the economic efficiency of IFN-? administration