Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2024-12-05
2026-07-05
Brief Summary
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To date, data at French national level are insufficient to describe the epidemiology of these infections, including their burden, and the potential protection of patients if vaccination coverage of health care professionals/patients is satisfactory. In addition, better understanding of the clinical characteristics of HAVRI will make it possible to identify potential sources of transmission as soon as possible and to implement appropriate hygiene measures.
We will set up a hospital-based prospective multicenter study in Bordeaux, Paris-Bichat, Dijon and Lyon, involving four inclusion services (geriatrics, internal medicine and transplantation) per hospital.
The main objective of this study is to calculate the incidence rate of hospital-acquired infections for three respiratory viruses; influenza, SARS-CoV-2 and syncytial respiratory virus (SRV), referred to as HARVI, in participating services.
Volunteered health care professionals or hospitalized patients presenting with influenza-like illness (ILI) at admission or during their stay in the participating centers will be eligible to be enrolled during the two inclusion periods: (mid-October 2024 to mid-April 2025 and mid-October 2025 to mid-April 2026).
For each patient/health care professional, a nasopharyngeal swab will be collected. A questionnaire including demographic data, medical history, vaccination, and clinical and biological data of the viral episode will also be completed by the study team. Patients tested positive for one of the viruses studied will be considered "cases" and patients tested negative as "controls".
The collected data will be pseudonymized before statistical analyses. Statistical analyses will consist of calculating incidence rates, attack rates overall and by causative virus and analysis of factors associated with the occurrence of HARVI.
The prospective design of the study will optimize the quality of the collected data (ex. consolidate the documentation of both the clinical picture and vaccination in patients and health care professionals by reducing memory bias) and allow to calculate the incidence rates, the crude and adjusted relative risks of HARVI according to the studied factors, and to describe multiple outcomes (hospitalization in intensive care units, death, etc.) based on the causative virus.
The results of this research project will allow to:
* obtain epidemiological indicators associated with HARVI;
* estimate the impact of HARVI on the prognosis of patients in hospital;
* assess the impact of HARVI on the total length of hospital stay;
* identify risk factors associated with HARVI;
* use the results as an argument for vaccination in order to increase vaccination coverage of healthcare workers.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Patients hospitalized in participating services for more than 24h
Patients hospitalized for more than 24 hours in the participating services (geriatric, internal medicine, transplantation) and who presents an influenza like illness (ILI) on admission or during hospital stay are eligible to participate. Following the signature of the consent, nasopharyngeal sample will be collected. Socio-demographic (questionnaire) and clinical information will be obtained using the study e-CRF.
Nasopharyngeal swab
Nasopharyngeal swab collection will be carried out in patients and health care professionals presenting an ILI during the study period. This will be done by trained clinical research associates after the signature of the consent. Only one nasopharyngeal sample is expected to be collected from each participant.
Questionnaire
questionnaire including demographic data, data on medical history and vaccination, and clinical and biological data on the viral episode.
Volunteered health care professionals
Volunteered health care professionals in the participating services (geriatric, internal medicine, transplantation) and who presents an influenza like illness (ILI) are eligible to participate. Following the signature of the consent, nasopharyngeal sample will be collected. Socio-demographic (questionnaire) and clinical information will be obtained using the study e-CRF
Nasopharyngeal swab
Nasopharyngeal swab collection will be carried out in patients and health care professionals presenting an ILI during the study period. This will be done by trained clinical research associates after the signature of the consent. Only one nasopharyngeal sample is expected to be collected from each participant.
Questionnaire
questionnaire including demographic data, data on medical history and vaccination, and clinical and biological data on the viral episode.
Interventions
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Nasopharyngeal swab
Nasopharyngeal swab collection will be carried out in patients and health care professionals presenting an ILI during the study period. This will be done by trained clinical research associates after the signature of the consent. Only one nasopharyngeal sample is expected to be collected from each participant.
Questionnaire
questionnaire including demographic data, data on medical history and vaccination, and clinical and biological data on the viral episode.
Eligibility Criteria
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Inclusion Criteria
* Hospitalized patient or health care professionals presenting an ILI on admission or during the stay, meeting the following definition: fever greater than 37.8° C in the absence of taking antipyretics and/or cough or pharyngeal pain.
* Signed consent form
Exclusion Criteria
* individuals deprived of their liberty by a judicial or administrative decision
* Individuals subject to psychiatric care
* Individuals admitted to a health or social establishment for purposes other than research
* Individuals under a legal protection measure (guardianship, curatorship)
* Individuals not affiliated to a social security insurance
18 Years
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Pellegrin Hospital
Bordeaux, , France
CHU Dijon
Dijon, , France
Edouard Herriot Hospital
Lyon, , France
Bichat Hospital
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Anne Marie ROGUES, Professor
Role: primary
Ludwig Serge AHO-GLELE, Professor
Role: primary
Philippe VANHEMS, Professor
Role: primary
Solen KERNEIS, Professor
Role: primary
Other Identifiers
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2024-A01267-40
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL23_1091
Identifier Type: -
Identifier Source: org_study_id