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临床试验/NCT02846311
NCT02846311已完成不适用

Prospective Evaluation of the Alere i Influenza A&B Nucleic Acid Amplification Versus Xpert Flu/RSV

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
Assessment of change of the Length of stay in the emergency service

研究概览

简要总结

The rapid and accurate detection of influenza virus in respiratory specimens is required for optimal management of patients with acute respiratory infections. Because of the variability of the symptoms and the numerous other causes of influenza-like illness, the diagnosis of influenza cannot be made on the basis of clinical criteria alone. Thus, rapid influenza diagnostic tests have been developed such as the Alere i Influenza A&B isothermal nucleic acid assay. Investigators prospectively evaluated the performance of the Alere i Influenza A&B assay in comparison with the routine Xpert Flu/RSV assay.

详细描述

Main objective / secondary:

It appears that so far the weight of the influenza disease, the limits of clinical diagnosis and validity of rapid diagnostic methods to emergencies are well studied and validated. However the potential organizational and economic benefit in emergency care services remains little known and rarely evaluated.

The significant improvement in diagnostic response time he has a real beneficial impact for the patient? For the organization of the emergency? Investigators propose to study the impact of the implementation of rapid diagnostic solution by molecular biology of influenza directly available in an adult emergency department, from a cohort of patients consulting in connection a flu-like illness. Investigators wish in particular to highlight the organizational and economic impact.

Methodology :

DESIGN:

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

  • Respiratory Symptoms include cough, dyspnea and / or
  • General symptoms: headache, myalgia, asthenia, anorexia ... and / or
  • Acute fever above 38 ° C
  • Patient consent.

排除标准

  • Major cognitive disorders
  • Patient under guardianship
  • Patient refusing to consent to research
  • Duplicate (patients who have had laboratory diagnosis of influenza in previous 7 days)
  • Patient not receiving social security

结局指标

主要结局

Assessment of change of the Length of stay in the emergency service

时间窗: Day 1

Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)

Assessment of change of Hospitalization rates

时间窗: Day 1

Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)

次要结局

  • Assessments of change of antibiotic treatment Costs(Day1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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