CTIS2022-502229-16-00招募中1 期
Human recombinant interferon gamma in the treatment of ventilator-acquired pneumonia in ICU patients. IGNORANT study - 69HCL22_0851
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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
排除标准
- •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)
研究者
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