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临床试验/NCT04448665
NCT04448665已完成不适用

The Empiric Antimicrobial Therapy: the Comparison of Initial Clinical Choice of Drugs With the Results of Microbiological Investigations - an Observational Study

Military Institute od Medicine National Research Institute1 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
267
试验地点
1
主要终点
Accuracy of initial empiric therapy

研究概览

简要总结

Hospital infections comprise about half of all undesirable complications related to hospital treatment. In case of bacterial infection administration of antimicrobial agent is a therapy of choice. For maximum effectiveness, antimicrobial agents should be administered quickly in optimal doses. Moreover, the therapeutic concentration of properly selected drugs should be achieved as soon as possible. The relation between delays in the administration of antibiotics and increased mortality is well known. That is why proper empiric therapy is so important. Before antimicrobial investigation is completed, which may last up to 72 hours, a wide-spectrum antimicrobial should be administered according to the type of infection, its origin, and the characteristics of the local pathogens.

The objective of this study is to compare the initial choice of empiric antimicrobial therapy and the results of both microbiological identification and susceptibility/resistance analysis of isolated pathogens.

This project was designed as a prospective cohort study. Analysis was performed in a large multidisciplinary academic hospital and trauma center. All decisions on empiric therapy with antimicrobial used in infections caused by multidrug-resistant pathogens, that are made in different hospital wards except intensive care, are required by hospital procedures to be confirmed by intensivists. In our analysis, the initial choice of empiric therapy in the hospital wards other than the critical care unit was compared with the results of microbiological investigations and susceptibility/resistance analyses of isolated pathogens.

Accurate microbial identification was performed with a VITEK® 2 automatic testing system. The microbroth dilution method with VITEK® 2 AST cards was used for the antibiotic susceptibility testing of isolated pathogens.

Microbiological analyses were performed between 2018 and 2020 according to the regulations of the European Committee on Antimicrobial Susceptibility (EUCAST, version 9.0, 2019) and the National Reference Centre for Susceptibility Testing (NRCST, Warsaw, Poland).

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Accuracy of initial empiric therapy

时间窗: Immediately after the completion of microbiological analyses

The comparison of initially administered antimicrobial agent with the results of microbiological analyses (susceptibility/resistance of the isolated pathogen).

次要结局

未报告次要终点

研究者

发起方
Military Institute od Medicine National Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dariusz Tomaszewski

MD, PhD

Military Institute od Medicine National Research Institute

研究点 (1)

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