Clinical trial NCT02198638: 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
Overall status: COMPLETED
Phase: NA
Conditions: Patient With Influenza Like Illness
Keywords: Influenza
Vaccination rate
Hospital acquired infection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 541
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients aged \< 18 years

Primary outcomes:
measure: Incidence of influenza among hospitalized patients according to % of influenza vaccination of HCW in short stay units
timeFrame: After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015)
Secondary outcomes:
measure: Estimation of influenza vaccine failure according to serotyping of viral strains
timeFrame: After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015)
measure: Does incidence of community influenza influence hospital acquired influenza infections
timeFrame: After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital Edouard Herriot
city: Saint Etienne
country: France
facility: Centre Hospitalier Universitaire - Saint Etienne
Study officials:
References:
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.