Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06643039

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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