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临床试验/NCT02392858
NCT02392858已完成不适用

Identification, in Patients Admitted to Intensive Care for Severe Influenza Respiratory Infection, of a Predictive Biomarker of Respiratory Distress

Hospices Civils de Lyon22 个研究点 分布在 1 个国家目标入组 227 人开始时间: 2015年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
227
试验地点
22
主要终点
Change in ratio of the partial pressure of oxygen in arterial blood (PaO2) to the inspired oxygen fraction (FiO2), from admission at 7 days post-admission

研究概览

简要总结

Influenza is a major cause of morbidity and mortality. The investigators first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Month 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient (Adult or Pediatric)
  • Hospitalized in reanimation
  • With a laboratory confirmed Influenza
  • That agree to take part in the study
  • Affiliated to National Health Insurance
  • For ancillary group :
  • Adult at least 60 years old
  • Presenting at hospital for a blood test

排除标准

  • non willing to participate
  • Influenza infection with no respiratory symptoms
  • pregnancy
  • For ancillary group :
  • Presence of immunodepression defined by:
  • Cancer, or cancer cured for less than 2 years
  • Corticosteroids, Methotrexate (MTX), anti Tumor Necrosis Factor (TNF), anti-CD20
  • Infection in progress (fever)

研究组 & 干预措施

influenza cohort

Other

Influenza is a major cause of morbidity and mortality. The investigators' first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation.

1 control group of 30 patients (ancillary study) will be constitued to have reference values of the HLA-G5 marker.

Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.

干预措施: influenza cohort (Other)

结局指标

主要结局

Change in ratio of the partial pressure of oxygen in arterial blood (PaO2) to the inspired oxygen fraction (FiO2), from admission at 7 days post-admission

时间窗: The first, third, fifth and seventh day of hospitalization in reanimation

decreased arterial PaO2/FiO2 ratio ≤ 100 mmHg (≤ 13.3 kPa)

次要结局

  • All cause mortality(90 days after hospitalization)
  • Extracorporeal membrane oxygenation requirement(90 days after hospitalization)
  • SOFA score (Adult) PELOD (Pediatric)(The first, third, fifth and seventh day of hospitalization in reanimation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (22)

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