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临床试验/NCT04453540
NCT04453540Unknown不适用

Impact of the Syndromic PCR System FilmArray on Management of ICU Patients With Severe Pulmonary Disease in the Context of the Covid-19 Pandemic.

Central Hospital, Nancy, France0 个研究点目标入组 150 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
主要终点
Therapeutic decision

研究概览

简要总结

The research aims to determine the impact of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalized in ICU for severe respiratory disease.

During the SARS-CoV-2 outbreak, the diagnosis of pneumonia has become considerably more complex as the biological, radiological and clinical criteria of covid-19 interfere with the standard criteria for the diagnosis of severe respiratory diseases. Moreover, patients with COVID-19 are at higher risk of developing other associated infections and thus, patients have therefore often been treated with antibiotics, adequately or not, due to difficulty to quickly identify the etiology of their symptoms with conventional methods.

In order to improve their treatment, both diagnostic and therapeutic, we set up a new syndromic molecular test in our laboratories to accelerate and improve the pneumonia management and antibiotic stewardship. This research will include 100 to 150 adult patients hospitalized in ICU during the first half of 2020. It will take place within the Nancy University Hospital and the Reims University Hospital, France.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients > 18 years affiliated to a social security system
  • Patients who have received complete information about the research and who have not objected to the use of its data
  • Patients with suspected SARS-Cov-2 infection
  • Patients for which a FilmArray test has been realized on its respiratory samples between 1st of March and 1st of July 2020.

排除标准

  • 未提供

结局指标

主要结局

Therapeutic decision

时间窗: 24 h following the FilmArray results

Antibiotic prescription modification following the FilmArray results as: * No prescription * No change in antibiotic utilization * Antibiotic initiation * Antibiotic escalation * Antibiotic de-escalation * Antibiotic discontinuation

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

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