Very Severe Malaria Treated by Intravenous Artesunate: Epidemiology, Management, Outcome and Prognostic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 578
- 试验地点
- 1
- 主要终点
- Mortality rate in the Group intravenous artesunate
研究概览
简要总结
In endemic areas, Plasmodium falciparum malaria exacts a huge public health toll, causing close to half a million deaths each year. In non-endemic industrialized areas, imported malaria may develop. In France, around 5000 imported cases occured annually, including 10-15% of severe malaria.
The criteria for defining severe malaria in endemic areas are established by the World Health Organization (WHO), and have been adjusted for severe imported malaria. In France, in order to optimize management, severe imported malaria is separated into two groups: very severe malaria (VSM) and less severe malaria (LSM). Briefly VSM included coma and/or shock and/or respiratory failure and/or acidosis and/or hyperlactatemia and/or death during hospitalization.
In France, severe imported malaria is treated with intravenous artesunate. Little is known about the management of imported VSM in the ICU with intravenous artesunate.
In a French national multicentric retrospective frame, the main objective of the present study is to describe in detail: epidemiology, management, outcome and prognostic of very severe imported malaria treated with intravenous artesunate during the period 2011-2019. The second objective is to retrospectively compare two groups : VSM treated with intravenous artesunate in the ICU during 2011-2019 versus VSM treated with intravenous quinine in the ICU during 2000-2010.
详细描述
See Brief Summary
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
- 否
入选标准
- •More than 18 year-old at the time of inclusion AND
- •Hospitalization in the ICU AND
- •For severe imported malaria (Plasmodium falciparum) AND
- •Very Severe Malaria episode defined during the 72 first hours as :
- •Neurological failure: Glasgow Coma Scale score<11 or repeated convulsions and/or
- •Shock: Systolic Blood Pressure<80 mmHg despite adequate fluid loading or need for vasoactive drugs and/or
- •Respiratory distress: Mechanical Ventilation or Non Invasive Ventilation ; or if spontaneous breathing: arterial pO2<60 mmHg or pulse oxymetry<92% in room air ; or Respiratory Rate>32/min and/or
- •Acidosis: plasma bicarbonate <15 mmol/l, or pH<7,35 and/or
- •Hyperlactatemia > 5 mmol/l and/or
- •Death during hospitalization for VSM
排除标准
- •Less than 18 year-old at the time of inclusion OR
- •Opposition to participate in the present study
结局指标
主要结局
Mortality rate in the Group intravenous artesunate
时间窗: At hospital discharge, an average of 1 month
Mortality reported as a mortality rate (%)
次要结局
- Mortality rates in the Group artesunate and Group quinine(At hospital discharge, an average of 1 month)
研究者
Dr Fabrice BRUNEEL
Investigator MD
Versailles Hospital