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临床试验/NCT01025180
NCT01025180终止4 期

Randomized Multicentre Prospective Study of Procalcitonin-guided Treatment on Antibiotic Use and Outcome in Severe Sepsis ICU Patients Without Obvious Infection

Brahms France18 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2007年12月1日最近更新:
适应症

试验速览

阶段
4 期
状态
终止
发起方
入组人数
62
试验地点
18
主要终点
rate of patients undergoing antibiotic treatment at D5.

研究概览

简要总结

A recent study has demonstrated that in low respiratory infections, a strategy using prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to antibiotics by 47% without prognostic modification.

The aim is to evaluate the impact on antibiotics consumption of an algorithm using procalcitonin level in patients exhibiting severe sepsis symptomatology but without clearly identified hosted germs or infectious centre.

This multicenter study is a randomized prospective open study involving 9 ICU departments in France, comparing two strategies on antibiotherapy treatment period one based on procalcitonin level(experimental group) the other on physician's appreciation(control group)

140 adult patients should be included with a severe sepsis symptomatology, whose infectious etiology has not been proven. The main non-inclusion criterium is: the presence of a pathogen agent or infectious centre clearly identified.

The primary outcome is the rate of patients undergoing antibiotic treatment at D5.

Secondary outcomes: duration of the antibiotic treatment, mortality rate and duration in stay in intensive care ward and evolution of the SOFA score between D0, D3 and D5.

Duration of patient enrollment is 30 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • hospitalized in resuscitation ward
  • severe sepsis symptomatology
  • at least 2 SIRS criteria
  • no infectious etiology detected
  • at least one organ deficiency

排除标准

  • the presence of a pathogen agent or infectious centre clearly identified
  • pregnancy
  • patients with therapeutic limitation
  • recent surgery
  • secondary neutropenia

结局指标

主要结局

rate of patients undergoing antibiotic treatment at D5.

时间窗: at D5

次要结局

  • evolution of the SOFA score between D0, D3 and D5.(D30)

研究者

发起方
Brahms France
申办方类型
Industry

研究点 (18)

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