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Clinical Trials/NCT02198638
NCT02198638CompletedNot Applicable

Influenza Vaccination of HCW and Hospital Acquired Influenza in Patients

Hospices Civils de Lyon2 sites in 1 country541 target enrollmentStarted: December 1, 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
541
Locations
2
Primary Endpoint
Incidence of influenza among hospitalized patients according to % of influenza vaccination of HCW in short stay units

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Patients aged < 18 years

Arms & Interventions

Patients or healthcare workers

Other

Intervention: A nasal swab (Biological)

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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