Actively Recruiting
Nosocomial Respiratory Virus Infection
Led by Hospices Civils de Lyon · Updated on 2024-12-10
1000
Participants Needed
4
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hospital-acquired Viral Respiratory Infections (HAVRI) are associated with substantial burden on health care systems. The prevention and control of these viral infections rely on multiple measures such as hand hygiene or wearing mask. However, vaccination remains the major preventive measure. 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.
CONDITIONS
Official Title
Nosocomial Respiratory Virus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years old
- Hospitalized patients or healthcare professionals with influenza-like illness (fever over 37.8°C without antipyretics, cough, or sore throat) at admission or during hospital stay
- Signed consent form
You will not qualify if you...
- Pregnant, giving birth, or breastfeeding women
- Individuals deprived of liberty by judicial or administrative decision
- Individuals under psychiatric care
- Individuals admitted to a health or social establishment for reasons other than research
- Individuals under legal protection measures (guardianship, curatorship)
- Individuals not affiliated with social security insurance
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Pellegrin Hospital
Bordeaux, France, 33076
Not Yet Recruiting
2
CHU Dijon
Dijon, France, 21079
Not Yet Recruiting
3
Edouard Herriot Hospital
Lyon, France, 69003
Actively Recruiting
4
Bichat Hospital
Paris, France, 75877
Not Yet Recruiting
Research Team
P
Philippe VANHEMS, MD, PhD
CONTACT
M
Mitra SAADATIAN-ELAHI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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