Asymptomatic Flu Project

Not Applicable

Completed

• Conditions: Influenza
• Interventions: Biological: Blood sampling; Other: Nasal swab

• Registration Number: NCT02868658
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-16
• Study Start: 2016-10-04
• Primary Completion: 2017-03-21
• Study Completion: 2017-03-21
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

Inclusion Criteria

• Volunteer health-care workers
• Working in the following wards: short-stay, inpatient (including ICU) and emergency

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Exclusion Criteria

• Presence of influenza symptoms at enrolment
• Programmed absence (maternity leave, vacation, etc.)
• Administrative agents

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health-care workers	Blood sampling	Health-care workers recruited in the study will have blood sampling and naso-pharyngeal bottle-brush sampling
Health-care workers	Nasal swab	Health-care workers recruited in the study will have blood sampling and naso-pharyngeal bottle-brush sampling

Primary Outcome Measures

Name	Time	Method
Incidence of influenza cases	6 months after inclusion	Incidence of asymptomatic and symptomatic influenza per 1000 days at risk among healthcare workers

Secondary Outcome Measures

Name	Time	Method
Incidence of influenza-like illness	6 months after inclusion	The objective is to calculate the incidence of influenza-like illness without virological confirmation
Stratified incidence ratios	6 months after inclusion	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
Number of sick-leave days per participating ward	6 months after inclusion	The objective is to estimate the professional impact of influenza in a population of healthcare workers
Fraction of asymptomatic influenza cases	6 months after inclusion	Fraction of asymptomatic influenza cases among patients with confirmed influenza infection (seroconversion)
proportion of health-care workers with Influenza vaccine coverage	6 months after inclusion	The objective is to estimate the vaccination coverage against influenza among health care workers

Trial Locations

Locations (1)

Edouard Herriot Hospital; Department of Epidemiology, Hygiene and Public Health; 🇫🇷 Lyon cedex 03, France