Effect of Influenza Vaccination of Healthcare Workers (HCW) on the Risk of Influenza in Patients Hospitalized in Short Stays Units
Primary Purpose
Patient With Influenza Like Illness
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
A nasal swab
Sponsored by
About this trial
This is an interventional prevention trial for Patient With Influenza Like Illness focused on measuring Influenza, Vaccination rate, Hospital acquired infection
Eligibility Criteria
Inclusion Criteria:
- All adults patients and healthcare workers of the participating units
- With Influenza Like Illness
Exclusion Criteria:
- Patients aged < 18 years
Sites / Locations
- Hospices Civils de Lyon - Hôpital Edouard Herriot
- Centre Hospitalier Universitaire - Saint Etienne
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients or healthcare workers
Arm Description
Outcomes
Primary Outcome Measures
Incidence of influenza among hospitalized patients according to % of influenza vaccination of HCW in short stay units
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
Estimation of influenza vaccine failure according to serotyping of viral strains
strains of confirmed influenza virus were analysed by reverse transcription-polymerase chain reaction on viral cultures.
Does incidence of community influenza influence hospital acquired influenza infections
comparison of results observed during the 2 seasons
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02198638
Brief Title
Effect of Influenza Vaccination of Healthcare Workers (HCW) on the Risk of Influenza in Patients Hospitalized in Short Stays Units
Official Title
Influenza Vaccination of HCW and Hospital Acquired Influenza in Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient With Influenza Like Illness
Keywords
Influenza, Vaccination rate, Hospital acquired infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
541 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients or healthcare workers
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
A nasal swab
Intervention Description
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 Measure Information:
Title
Incidence of influenza among hospitalized patients according to % of influenza vaccination of HCW in short stay units
Description
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.
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)
Secondary Outcome Measure Information:
Title
Estimation of influenza vaccine failure according to serotyping of viral strains
Description
strains of confirmed influenza virus were analysed by reverse transcription-polymerase chain reaction on viral cultures.
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)
Title
Does incidence of community influenza influence hospital acquired influenza infections
Description
comparison of results observed during the 2 seasons
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All adults patients and healthcare workers of the participating units
With Influenza Like Illness
Exclusion Criteria:
Patients aged < 18 years
Facility Information:
Facility Name
Hospices Civils de Lyon - Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Centre Hospitalier Universitaire - Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35382916
Citation
Amour S, Benet T, Regis C, Robert O, Fontana L, Lina B, Pozzetto B, Berthelot P, Vanhems P. Effect of influenza vaccination among healthcare workers on hospital-acquired influenza in short-stay hospitalized patients: A multicenter pilot study in France. Infect Control Hosp Epidemiol. 2022 Dec;43(12):1828-1832. doi: 10.1017/ice.2022.68. Epub 2022 Apr 6.
Results Reference
derived
Learn more about this trial
Effect of Influenza Vaccination of Healthcare Workers (HCW) on the Risk of Influenza in Patients Hospitalized in Short Stays Units
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