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临床试验/EUCTR2021-002197-78-FR
EUCTR2021-002197-78-FR进行中(未招募)1 期

Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive CareAcronym: ASPIC - ASPIC

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 590 人开始时间: 2022年1月18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)
入组人数
590

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

  • Adult patient is =18 and
  • - Patient under MV
  • - Diagnosis of microbiologically confirmed of first episode of VAP
  • - Initial adequate empiric antibiotic therapy
  • -Written informed consent from the patient or a legal representative if appropriate. If absence of a legal representative the patient may be included in emergency procedure
  • 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 590
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 590

排除标准

  • Patient under selective decontamination of the digestive tract
  • - Concomitant extra-respiratory infection requiring antibiotic therapy at the moment of inclusion
  • - Inclusion in another interventional study concerning antimicrobial strategies
  • - Moribund (IGS II>80)
  • - Thoracic trauma with Abbreviated Injury Scale (AIS) thorax ? 3
  • - Severely immunocompromised patients (such as congenital immunodeficiency , neutropenia (<1leucocyte/ml or <0.5 neutrophil/ml) or acute hematologic malignancy or stem cell transplant, HIV infection with CD4 count below 200/mm3
  • - VAP due to: Pseudomonas aeruginosa, Carbapenem-resistant Acinetobacter spp, Carbapenem-resistant Enterobacteriaceae
  • - Bacterial VAP in a context of COVID-19 or other confirmed viral pneumonia
  • - No health insurance coverage

研究者

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