De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis: A Randomized Clinical Trial (DEA Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- the length of stay
研究概览
简要总结
Rational: Severe sepsis is one of the leading cause of mortality in intensive care unit patients. Early initiation of an appropriate empirical antimicrobial therapy is associated with improved outcomes. In order to avoid an increase of selection pressure and the emergence of multidrug resistant pathogens, guidelines recommend to streamline the antimicrobial therapy after the identification of the pathogen responsible for infection. This strategy has been evaluated in several observational studies. However, at the bedside, few randomized clinical trials tested this strategy prospectively.
Method: the investigators conduct a randomized clinical trial comparing a strategy based on de-escalation (streamlining of the empirical antimicrobial therapy) and a conservative strategy (continuation of the empirical antimicrobial therapy). The investigators first aim was to show that a strategy based on de-escalation is not inferior to a conservative strategy in terms of intensive care unit length of stay. Secondary aims are to compare the rate of mortality rate, the emergence of multidrug resistant pathogens, and the feasibility of de-escalation. The study is performed in nine intensive care units from four institutions, and 120 patients are required to validate the investigators hypothesis. New technologies for the rapid diagnosis of severe infections are investigated in an ancillary study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Major Subject;
- •Subject having a sepsis engraves(burns) defined according to the following criteria during the initiation of the probability antibiotic treatment:
- •Criteria of SIRS [ 14 ],
- •And a suspected infection,
- •And a failure of organ: low blood pressure, respiratory failure, coma, hepatic insufficiency, renal insufficiency, thrombopénia, spontaneous extension of the TCA,
- •Subject for which an antibiotic treatment was begun within 6 hours following the diagnosis of sepsis engraves(burns);
- •Subject for which a taking with microbiological aim was made within 48 hours following the diagnosis of sepsis
排除标准
- •Minor Subject, pregnant or breast-feeding woman;
- •Neutropénia (PN < 1000 / mm3);
- •Absence of identification of a microorganism in the microbiological examinations;
- •Absence of Social Security;
- •Subject deprived of freedom or under guardianship;
- •Subject for which the lit(enlightened) consent is not collected(taken in) (itself and/or reliable person).
研究组 & 干预措施
a strategy based on de-escalation
干预措施: streamlining of the empirical antimicrobial therapy (Procedure)
a conservative strategy
干预措施: continuation of the empirical antimicrobial therapy (Procedure)
结局指标
主要结局
the length of stay
时间窗: 24 months
he deadline in days sold enters the diagnosis of sepsis engrave or toxic shock and the exit of resuscitation.
次要结局
- Lasted administration of catécholamines(24 months)
- Lasted mechanical ventilation(breakdown)(24 months)
- Mortality in resuscitation(24 months)
- Lasted treatment antibiotic(24 MONTHS)