EUCTR2020-005768-74-NL进行中（未招募）1 期
PERSONALIZED IMMUNOTHERAPY IN SEPSIS: A MULTICENTRE AND MULTINATIONAL, DOUBLE-BLIND, DOUBLE-DUMMY RANDOMIZED CLINICAL TRIAL (THE IMMUNOSEP TRIAL)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •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
排除标准
- •Age below 18 years.
- •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 coagulase-negative 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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