NCT02868658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 4, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2017

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

August 11, 2016

Last Update Submit

December 13, 2025

Conditions

Influenza

Keywords

Influenzahealth care workersnosocomialasymptomaticFrance

Outcome Measures

Primary Outcomes (1)

  • Incidence of influenza cases

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

    6 months after inclusion

Secondary Outcomes (5)

  • Fraction of asymptomatic influenza cases

    6 months after inclusion

  • Stratified incidence ratios

    6 months after inclusion

  • Incidence of influenza-like illness

    6 months after inclusion

  • proportion of health-care workers with Influenza vaccine coverage

    6 months after inclusion

  • Number of sick-leave days per participating ward

    6 months after inclusion

Study Arms (1)

Health-care workers

EXPERIMENTAL

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

Biological: Blood samplingOther: Nasal swab

Interventions

Blood samplingBIOLOGICAL
Health-care workers
Nasal swabOTHER
Health-care workers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lyon, 69437, France

Location

Related Publications (1)

  • 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.

    PMID: 32750120RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

October 4, 2016

Primary Completion

March 21, 2017

Study Completion

March 21, 2017

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)