Patient With Influenza Like Illness Clinical Trial
Official title:
Influenza Vaccination of HCW and Hospital Acquired Influenza in Patients
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.
| Status | Completed |
| Enrollment | 541 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - All adults patients and healthcare workers of the participating units - With Influenza Like Illness Exclusion Criteria: - Patients aged < 18 years |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| France | Hospices Civils de Lyon - Hôpital Edouard Herriot | Lyon | |
| France | Centre Hospitalier Universitaire - Saint Etienne | Saint Etienne |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015) | No |
| Secondary | 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. | After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015) | No |
| Secondary | Does incidence of community influenza influence hospital acquired influenza infections | comparison of results observed during the 2 seasons | After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015) | No |