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临床试验/NCT02203110
NCT02203110Unknown不适用

The Impact of Simultaneous Presence of Viral and Bacterial Pathogens on Therapy and Course of Severe Pneumonia

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Rate of changes in empirical antibiotic therapy due to broad microbiological diagnostic

研究概览

简要总结

The purpose of the study is to determine if the clinical course of pneumonia is more severe when both, bacterial and viral pathogens are find as possible causative agent and how does it affect treatment.

详细描述

Basic demographic data of the patients (age, gender), data on concomitant diseases and epidemiological circumstances will be collected

Severity of illness will be assessed by APACHE II (at day 1) and SOFA (at day 1,2,3 and 7) scoring system

Following laboratory tests will be performed at day 1, 2,3 and 7.:

  • blood count analysis
  • differential blood count
  • C- reactive protein, procalcitonin
  • glucose, urea, potassium, sodium, chloride, magnesium, creatinine, bilirubin, protein, albumin, alkaline phosphatase, aspartate aminotransferase, alanine transaminase, gamma-glutamyl transpeptidase , alpha-amylase, lipase, creatine kinase, lactate dehydrogenase, myoglobin
  • arterial blood gas analysis
  • tests of hemostasis.

Additional 2 mL of blood will be taken at day 1 and day 21 (or later), due to paired serologic testing

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • diagnosis of
  • severe community acquired pneumonia or
  • severe hospital acquired pneumonia or
  • ventilator--associated pneumonia

排除标准

  • antibiotic treatment of actual episode of pneumonia for more than 24 hours

结局指标

主要结局

Rate of changes in empirical antibiotic therapy due to broad microbiological diagnostic

时间窗: each patient will be assessed at enrollment and follow-up for 2 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Primoz Karner

MD

University Medical Centre Ljubljana

研究点 (1)

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