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Asymptomatic Flu Project (AFP)

Primary Purpose

Influenza

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Nasal swab
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, health care workers, nosocomial, asymptomatic, France

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Edouard Herriot Hospital; Department of Epidemiology, Hygiene and Public Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health-care workers

Arm Description

Health-care workers recruited in the study will have blood sampling and naso-pharyngeal bottle-brush sampling

Outcomes

Primary Outcome Measures

Incidence of influenza cases
Incidence of asymptomatic and symptomatic influenza per 1000 days at risk among healthcare workers

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2016
Last Updated
February 15, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02868658
Brief Title
Asymptomatic Flu Project
Acronym
AFP
Official Title
Incidence of Symptomatic and Asymptomatic Influenza Among Healthcare Workers : A Multicenter Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 4, 2016 (Actual)
Primary Completion Date
March 21, 2017 (Actual)
Study Completion Date
March 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, health care workers, nosocomial, asymptomatic, France

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
289 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health-care workers
Arm Type
Experimental
Arm Description
Health-care workers recruited in the study will have blood sampling and naso-pharyngeal bottle-brush sampling
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Type
Other
Intervention Name(s)
Nasal swab
Primary Outcome Measure Information:
Title
Incidence of influenza cases
Description
Incidence of asymptomatic and symptomatic influenza per 1000 days at risk among healthcare workers
Time Frame
6 months after inclusion
Secondary Outcome Measure Information:
Title
Fraction of asymptomatic influenza cases
Description
Fraction of asymptomatic influenza cases among patients with confirmed influenza infection (seroconversion)
Time Frame
6 months after inclusion
Title
Stratified incidence ratios
Description
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
Time Frame
6 months after inclusion
Title
Incidence of influenza-like illness
Description
The objective is to calculate the incidence of influenza-like illness without virological confirmation
Time Frame
6 months after inclusion
Title
proportion of health-care workers with Influenza vaccine coverage
Description
The objective is to estimate the vaccination coverage against influenza among health care workers
Time Frame
6 months after inclusion
Title
Number of sick-leave days per participating ward
Description
The objective is to estimate the professional impact of influenza in a population of healthcare workers
Time Frame
6 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Edouard Herriot Hospital; Department of Epidemiology, Hygiene and Public Health
City
Lyon cedex 03
ZIP/Postal Code
69437
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32750120
Citation
Benet T, Amour S, Valette M, Saadatian-Elahi M, Aho-Glele LS, Berthelot P, Denis MA, Grando J, Landelle C, Astruc K, Paris A, Pillet S, Lina B, Vanhems P; AFP Study Group. Incidence of Asymptomatic and Symptomatic Influenza Among Healthcare Workers: A Multicenter Prospective Cohort Study. Clin Infect Dis. 2021 May 4;72(9):e311-e318. doi: 10.1093/cid/ciaa1109.
Results Reference
derived

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Asymptomatic Flu Project

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