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

Hellenic Institute for the Study of Sepsis0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年4月9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. More precisely, sepsis is defined
•as the presence of total SOFA (sequential organ failure assessment score) equal
•to 2 or more for patients who are admitted with infection at the emergency
•department OR as any increase of admission SOFA by 2 or more points for
•patients already hospitalized.
•- Patients with signs of fulminant hyper-inflammation or sepsis-associated
•immunoparalysis. Since the state of hyper-inflammation is considered more
•life-threatening than the state of immunoparalysis, patients with lab findings
•of both immune states are allocated to treatment targeting hyper-inflammation.
•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.

•- Age below 18 years.
•- Denial for written informed consent.
•- Acute pyelonephritis or intraabdominal infection, meningitis or skin
•- 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 coagulase-negative
•staphylococci or skin commensals or catheter-related infections cannot be
•- 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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