跳至主要内容
临床试验/NCT05193045
NCT05193045进行中(未招募)不适用

Prognosis of Klebsiella ESBL Sepsis: Role of 2-HYDRoxy-myristate in Endotoxin Structure

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
28
试验地点
1
主要终点
Role of 2-hydroxymyristate within lipid A of lipopolysaccharide in the prognosis of ESBL-producing Klebsiella infections in the ICU

研究概览

简要总结

Infections constitute a multiple and heterogeneous set of pathologies, and the first cause of mortality worldwide. Among them, sepsis is a more recent nosological entity, including the most severe forms of acute infectious pathologies, its frequency increasing considerably over time. It is considered to be the cause of more than 27 million deaths per year, more than 4,000 deaths per day in the United States and about 200 deaths per day in intensive care units in France.

The occurrence of hemodynamic failure within visceral damage is a poor prognostic factor, the lethality in this situation can reach 60% of affected patients. The amount of organ dysfunction is also prognostic. More worryingly, the initial mortality is aggravated by the persistence of the negative evolution after hospital treatment, the 5-year prognosis being significantly more severe in the population of patients treated for sepsis than in the general population, particularly in the case of respiratory or cardiovascular damage during the stay in intensive care. The most frequent causes of these severe infections in the ICU are lower respiratory infections, particularly pneumonia acquired under mechanical ventilation, urinary tract infections and digestive tract infections.

Sepsis corresponds to an infection of particular severity, which results in the association of organ failures, the type and severity of which vary according to the patient, the origin of the infection and the pathogen responsible. The severity of the picture will require specific management and may necessitate the introduction of organ supplements or even lead to death in the most serious forms.

Infections by enterobacteria and in particular Klebsiella spp. are frequent in the intensive care unit. The association with antibiotic resistance and especially with ESBL production is a daily clinical situation. During these infections, the prognosis is variable, sometimes very poor, without it being possible to determine whether this evolution is due to antibiotic resistance or to the virulence of the pathogen. The objective of this work is to study the structure of lipid A of ESBL-producing Klebsiella strains responsible for nosocomial infections. This study is part of the "EVENT" protocols of which it is an ancillary analysis.

The objective of this study is to evaluate the role of the presence of 2-hydroxymyristate within lipid A of the lipopolysaccharide in the prognosis of ESBL-producing Klebsiella infections in the ICU. The secondary objectives correspond to the evaluation of the vital prognosis according to the infected organ (lung, kidney, digestive system), and the presence of 2-hydroxymyristate and the risk of bacteremia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Patient whose age is ≥ 18 years
  • Patient hospitalized in an intensive care unit
  • Patient with a nosocomial infection with ESBL-producing Klebsiella
  • French-speaking patient

排除标准

  • Patient with a severe psychiatric disorder
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient who objects to the use of his or her data for this research

结局指标

主要结局

Role of 2-hydroxymyristate within lipid A of lipopolysaccharide in the prognosis of ESBL-producing Klebsiella infections in the ICU

时间窗: Day 128

This outcome corresponds to the mortality in intensive care.

次要结局

  • Evaluation of the vital prognosis according to the infected organ (lung, kidney, digestive system) at 3 months.(Month 3)
  • Evaluation of the vital prognosis according to the infected organ (lung, kidney, digestive system) at day 28(Day 28)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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