PERSONALIZED IMMUNOTHERAPY IN SEPSIS: A MULTICENTRE AND MULTINATIONAL, DOUBLE-BLIND, DOUBLE-DUMMY RANDOMIZED CLINICAL TRIAL (THE IMMUNOSEP TRIAL) - ImmunoSep

Hellenic Institute for the Study of Sepsis0 个研究点目标入组 280 人开始时间: 2022年11月18日最近更新: 2023年8月28日

适应症

试验速览

暂无简介。

•Age equal to or above 18 years.
•Both genders.
•In case of women, unwillingness to become pregnant during the study period.
•Written informed consent provided by the patient or by one first degree relative/spouse in case of patients unable to consent.
•Community-acquired pneumonia (CAP) or hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP) or primary bacteremia (BSI).
•Sepsis defined by the Sepsis-3 definitions.
•Patients with signs of fulminant hyper-inflammation or sepsis associated immunoparalysis. It is explicitly stated that patients diagnosed with COVID-19 infection may participate only in the fulminant hyper-inflammation arm.
•Time from classification into sepsis by the Sepsis-3 definitions and start of blind intervention less than 72 hours.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 180

•Denial for written informed consent.
•Acute pyelonephritis or intraabdominal infection, meningitis or skin infection.
•Any stage IV malignancy.
•Neutropenia defined as an absolute neutrophil count lower than 1,500/mm3.
•Any 'do not resuscitate' decision in the hospital.
•In the case of BSI, patients with blood cultures growing coagulasenegative staphylococci or skin commensals or catheter-related infections cannot be enrolled.
•Active tuberculosis (TB) as defined by the co-administration of drugs for the treatment of TB.
•Infection by the human immunodeficiency virus (HIV).
•Any primary immunodeficiency.
•Oral or intravenous intake of corticosteroids at a daily dose equal or greater than 0.4 mg/kg prednisone or greater the last 15 days.
•Any anti-cytokine biological treatment the last one month.
•Medical history of systemic lupus erythematosus.
•Medical history of multiple sclerosis or any other demyelinating disorder.
•Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study.

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