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NCT02868658 Clinical Trial

Asymptomatic Flu Project

Influenza Clinical Trial

— AFP  

Official title:
Incidence of Symptomatic and Asymptomatic Influenza Among Healthcare Workers : A Multicenter Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02868658
Other study ID # 69HCL16_0095
Secondary ID
Status Completed
Phase N/A
First received August 11, 2016
Last updated February 15, 2018
Start date October 4, 2016
Est. completion date March 21, 2017

Study information
Verified date February 2018
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Although clinical presentation of influenza is often symptomatic, asymptomatic cases also occur. The knowledge of the incidence of asymptomatic influenza among healthcare workers is very important because of the risk of cross-transmission to hospitalized patients. The principal objective of the study is to estimate the incidence of symptomatic and asymptomatic influenza among healthcare workers in short-stay wards. The results of this study will lead to a better understanding of the burden of asymptomatic influenza among healthcare workers and might be used as an argument to increase influenza vaccine coverage among healthcare workers.

Recruitment information / eligibility
Status Completed
Enrollment 289
Est. completion date March 21, 2017
Est. primary completion date March 21, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Volunteer health-care workers

- Working in the following wards: short-stay, inpatient (including ICU) and emergency

Exclusion Criteria:

- Presence of influenza symptoms at enrolment

- Programmed absence (maternity leave, vacation, etc.)

- Administrative agents

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Blood sampling

Other:
• Nasal swab

Locations
Country Name City State
France Edouard Herriot Hospital; Department of Epidemiology, Hygiene and Public Health Lyon cedex 03

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of influenza cases Incidence of asymptomatic and symptomatic influenza per 1000 days at risk among healthcare workers 6 months after inclusion
Secondary Fraction of asymptomatic influenza cases Fraction of asymptomatic influenza cases among patients with confirmed influenza infection (seroconversion) 6 months after inclusion
Secondary Stratified incidence ratios The objective is to compare the proportion of asymptomatic influenza among vaccinated and unvaccinated healthcare workers, stratified on the type of influenza virus , gender, age, and other covariates 6 months after inclusion
Secondary Incidence of influenza-like illness The objective is to calculate the incidence of influenza-like illness without virological confirmation 6 months after inclusion
Secondary proportion of health-care workers with Influenza vaccine coverage The objective is to estimate the vaccination coverage against influenza among health care workers 6 months after inclusion
Secondary Number of sick-leave days per participating ward The objective is to estimate the professional impact of influenza in a population of healthcare workers 6 months after inclusion
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