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Effect of Influenza Vaccination of Healthcare Workers (HCW) on the Risk of Influenza in Patients Hospitalized in Short Stays Units

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ClinicalTrials.gov Identifier: NCT02198638
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Patient With Influenza Like Illness Biological: A nasal swab Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 541 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Influenza Vaccination of HCW and Hospital Acquired Influenza in Patients
Study Start Date : December 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patients or healthcare workers Biological: A nasal swab
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Estimation of influenza vaccine failure according to serotyping of viral strains [ 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) ]
    strains of confirmed influenza virus were analysed by reverse transcription-polymerase chain reaction on viral cultures.

  2. Does incidence of community influenza influence hospital acquired influenza infections [ 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) ]
    comparison of results observed during the 2 seasons



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients aged < 18 years

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198638


Locations
France
Hospices Civils de Lyon - Hôpital Edouard Herriot
Lyon, France, 69003
Centre Hospitalier Universitaire - Saint Etienne
Saint Etienne, France, 42055
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02198638     History of Changes
Other Study ID Numbers: 2013.814
2012-A01503-40 ( Other Identifier: (N°ID-RCB) France: Agence Nationale de Sécurité du Médicament et des produits de santé )
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

Keywords provided by Hospices Civils de Lyon:
Influenza
Vaccination rate
Hospital acquired infection

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs