跳至主要内容
临床试验/NCT05671159
NCT05671159进行中(未招募)不适用

COMPArative Study of the Consequence on innaTe Immune Response du to Bacterial or Viral Infection in Patients Admitted to Intensive Care Unit

University Hospital, Limoges2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2023年2月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
38
试验地点
2
主要终点
Granules expressing CD123 and CD64

研究概览

简要总结

Patient admitted in intensive care unit (ICU) for acute infection whether it be viral or bacterial had major impairment of the immune response. One hallmark of the immune impairment is presence of immature granulocyte (IG) in blood. Depend of initial trigger (virus or bacteria) concentration, phenotype and function of IG seems to be different. In this prospective trial, immature granulocytes will be analyzed in depth in immunocompetent patients hospitalized in the intensive care unit for an acute viral or bacterial infection.

详细描述

Granulocytes are a key actor of immune response during acute viral or bacterial infection. During their maturation in bone marrow they went from immature form to mature form. In physiological condition only mature form are present in blood. However, in case of acute viral or bacterial infection, immature granulocytes (CD10low/CD16low) could be released in blood. But concentration, phenotype and function of these IG seems to be different between bacterial and viral infection. Indeed, in bacterial infection, concentration of IG is high (> 20%) and they expressed CD64 and CD123. In case of viral infection, blood concentration of IG is lower and they expressed CD62-L. These phenotype differences are probably associated with functional modification. A more precise characterization of the phenotype and functions of IG according to the stimulus (bacterial or viral) could provide a better understanding of the innate immune response in patients hospitalized in ICU for acute infection. The investigators will analysis by flow cytometry IG subsets (PDL1 CD62L LOX-1 CD45 CD64 CD15 CD123 CD16 CD10 CRTH2) of adult immunocompetent patient hospitalized in ICU for less than 24 hours for acute infection. Transcriptomic and cytokine analysis will be also performed. Infectious status will be validated by a blind adjudication committee which will classify patient in certain bacterial infection, certain viral infection, co-infection and no confirmed infection.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Bacterial infection:
  • Adult patient hospitalized for less than 24 hours in ICU for community documented sepsis
  • Vasopressor support
  • SOFA score > 4
  • Viral infection:
  • Adult patient hospitalized for less than 24 hours in ICU for confirmed viral acute infection.
  • High flow oxygen, non-invasive or invasive ventilation since less than 24 hours
  • Moderate to severe ARDS with PaO2/FiO2 < 200mmHg and a FiO2 ≥ 0.6.

排除标准

  • Bacterial infection:
  • Antibiotics or hospitalized in ICU in the previous 3 months
  • Immunocompromized patient
  • Ongoing acute or chronic viral infection
  • Viral infection:
  • Antibiotics or hospitalized in ICU in the previous 3 months
  • Immunocompromized patient
  • Current antibiotics
  • Ongoing chronic viral infection.

研究组 & 干预措施

bacterial infection

Experimental

干预措施: Blood sample (Other)

viral infection

Other

干预措施: Blood sample (Other)

结局指标

主要结局

Granules expressing CD123 and CD64

时间窗: Day 0

Measurement by flow cytometry of the percentage of granules expressing CD123 and CD64 depending on the type of infection (viral or bacterial).

次要结局

  • Immune functions genes expression(Day 0)
  • blood concentrations of cytokines(Day 0)
  • Sequential Organ Failure Assessment (SOFA) score(Day 0)
  • blood concentrations of activation markers(Day 0)
  • granules expressing CD62-L(Day 0)

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

COMPArative Study of the Consequence on innaTe... | 临床试验