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临床试验/NCT01089400
NCT01089400已完成不适用

Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage in Patients Requiring Mechanical Ventilation in Intensive Care Unit

Institut National de la Santé Et de la Recherche Médicale, France2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
immunological parameters in blood and bronchoalveolar lavage fluid

研究概览

简要总结

The influenza A/H1N1v pandemic virus causes severe pneumonia that can lead to acute respiratory distress syndrome and death even in healthy young individuals. The respective roles of viral replication, bacterial infection and immune alterations of the host during such severe influenza H1N1v infection need to be clarified in order to optimize patients care. In this context, we aim to study immune and virological parameters in bronchoalveolar lavage fluid during severe influenza A/H1N1v infection with pulmonary involvement in intensive care unit. Results will be correlated to bacterial or viral pulmonary co-infections and to peripheral blood immune and virological parameters.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Suspected influenza A/H1N1 infection
  • Diffuse bilateral pneumonia <96h with acute lung injury or respiratory distress syndrome
  • Invasive or non-invasive ventilation in intensive care unit
  • Age > 13

排除标准

  • Other cause identified of acute lung injury or acute respiratory distress syndrome
  • Contraindicated bronchoalveolar lavage

结局指标

主要结局

immunological parameters in blood and bronchoalveolar lavage fluid

时间窗: day 0 and day 5-7 of ventilation for both blood and BAL, day 30 and month 5 for blood

次要结局

  • virological parameters in nose, broncho-alveolar lavage and peripheral blood(day 0 and day 5-7 of ventilation)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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