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临床试验/EUCTR2016-000735-41-FR
EUCTR2016-000735-41-FR进行中(未招募)1 期

Antimicrobial treatment in patients with ventilator-associated tracheobronchitis: a prospective randomized placebo-controlled double-blind multicenter trial - TAVeM 2

CHRU LILLE0 个研究点目标入组 315 人开始时间: 2016年11月15日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
315

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • All adult patients with a first episode of VAT diagnosed >48 hours after starting invasive mechanical ventilation are eligible for this study.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 315
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • long-term tracheostomy at ICU admission
  • -modified Clinical Pulmonary Infection Score (CPIS) =6 at the day of randomization
  • -patients who develop VAP before VAT
  • -patients already receiving antibiotics active against all the microorganisms responsible for VAT
  • -severe immunosuppression
  • -pregnancy or breastfeeding
  • -patients <18 years
  • -patients already included in another study, with potential interaction with the primary objective of the current study
  • -absence of social insurance
  • -patients under guardianship
  • -known resistance of bacteria responsible for VAT to imipenem and ciprofloxacin
  • -treatment limitation decisions
  • -moribund patients
  • -allergy to any of study drugs

研究者

发起方
CHRU LILLE

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