Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643039
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Nosocomial Respiratory Virus Infection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hospital-acquired Respiratory Viral Infection a Prospective Multicenter Study in France
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOSOVIRUS
Brief Summary:
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 professionalspatients 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 patienthealth 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
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 professionalspatients 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 patienthealth 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None