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临床试验/NCT03039998
NCT03039998已完成不适用

Validity of Biological Material Sampling in Patients With Hospital-acquired Pneumonia

University Hospital Olomouc0 个研究点目标入组 56 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
主要终点
Sensitivity and specificity of diagnostic methods etiological agents HAP. Scale: sensitivity and specificity of each method.

研究概览

简要总结

The main objective of project is to compare validity of sampling methods performed routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to bronchoscopy-assisted protected brush method. Evaluation of the present clinical praxis using bronchial secretion sampling in HAP diagnostics and detection of the most common etiological agents in patients with HAP are other priorities of the project. Aiming to confirm or exclude the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens transmission molecular biology analysis of etiological agents is performed. Finally, percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be observed.

详细描述

The main objective of project will be comparing validity of sampling methods performed routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to bronchoscopy-assisted protected brush method. Obtained results of different methods will enable to determine if the bronchial secretion sample, stomach content sample or oropharyngeal smear are comparable to precise but technically difficult protected brush. Evaluation of the present clinical praxis using bronchial secretion sampling in HAP diagnostics and detection of the most common etiological agents in patients with HAP will be other priorities of the project. The role of atypical and fungal pathogens in HAP initiation will be discovered as well. Aiming to confirm or exclude the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens transmission molecular biology analysis of etiological agents will be performed. Finally, percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be observed.

Project fulfills program objectives of molecular-biologic approaches and research support in infectious diseases domain. It will make contribution to faster and more precise HAP diagnosis and adequate antibiotic therapy.

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

  • clinical signs of HAP
  • need for intubation and mechanical ventilation

排除标准

  • inability to obtain samples in 24 hours after clinical diagnosis of HAP

结局指标

主要结局

Sensitivity and specificity of diagnostic methods etiological agents HAP. Scale: sensitivity and specificity of each method.

时间窗: 72 hours

Obtaining 4 types of agent samples: endotracheal aspirate, gastric aspirate, oropharyngeal swab and protected specimen brushing when clinical signs of HAP arisen and after 72 hours

次要结局

未报告次要终点

研究者

发起方
University Hospital Olomouc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Radovan Uvizl

Radovan Uvízl, MD, PhD

University Hospital Olomouc

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