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临床试验/NCT02198638
NCT02198638已完成不适用

Influenza Vaccination of HCW and Hospital Acquired Influenza in Patients

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 541 人开始时间: 2013年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
541
试验地点
2
主要终点
Incidence of influenza among hospitalized patients according to % of influenza vaccination of HCW in short stay units

研究概览

简要总结

Hospital acquired influenza is associated with significant morbidity and mortality in hospitalized patients notably elderly patients. Vaccination of HCW is recommended to prevent influenza transmission in healthcare setting.

Outbreaks of hospital acquired influenza were reported in stays with high vaccine coverage in patients (higher than 85%). It is necessary to underline that an adequate vaccine cover in the elderly population will not necessarily result in a total control of the incidence. Consequently, the prevention of influenza outbreaks in this vulnerable population must also include the reduction of the exposure to the influenza viruses, in particular thanks to the vaccination of HCW.

A pilote case-control study, implemented in Edouard Herriot hospital (at Lyon University hospitals), indicates that a shielding effect of more than 35% of vaccinated HCW on hospital acquired influenza among patients (Bénet et al.; BMC Infectious Diseases 2012). The results suggest a protective effect but investigations, carried out on a more important sample are needed to validate the benefit of HCW vaccination.

The aim of this prospective multicentric cohort study is to estimate incidence of influenza among hospitalized patients according to % of influenza vaccination of HCW in short stay units.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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

  • All adults patients and healthcare workers of the participating units
  • With Influenza Like Illness

排除标准

  • Patients aged < 18 years

研究组 & 干预措施

Patients or healthcare workers

Other

干预措施: A nasal swab (Biological)

结局指标

主要结局

Incidence of influenza among hospitalized patients according to % of influenza vaccination of HCW in short stay units

时间窗: After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015)

Study participation was proposed to each patient who presented ILI (influenza like illness) at admission or during hospitalization. ILI was defined as fever \>37.8°C or cough or sore throat. Vaccination against influenza during the ILI season was collected by oral interview. After the interview, a nasal swab was performed by a research assistant and influenza virus infection was confirmed by enzyme-linked immunosorbent assay and reverse transcription-polymerase chain reaction on viral cultures.

次要结局

  • Estimation of influenza vaccine failure according to serotyping of viral strains(After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015))
  • Does incidence of community influenza influence hospital acquired influenza infections(After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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