Nosocomial Respiratory Virus Infection (NOSOVIRUS)

Hospital-acquired Respiratory Viral Infection: A Prospective Multicenter Study in France

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.

Study Overview

• Status: Recruiting
• Conditions: Nosocomial Infections
• Intervention / Treatment: Biological: Nasopharyngeal swab; Other: Questionnaire

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe VANHEMS, MD, PhD; Phone Number: +33 4 72 11 07 20; Email: Philippe.vanhems@chu-lyon.fr
• Study Contact Backup: Name: Mitra SAADATIAN-ELAHI; Phone Number: +33 4 72 11 07 18; Email: Mitra.elahi@chu-lyon.fr

Study Locations

• France
  • Bordeaux, France, 33076
    • Not yet recruiting
    • Pellegrin Hospital
    • Contact: Anne Marie ROGUES, Professor; Phone Number: +33 5 56 79 55 53; Email: anne-marie.rogues@chu-bordeaux.fr
    • Principal Investigator: Anne Marie ROGUES, Professor
  • Dijon, France, 21079
    • Not yet recruiting
    • CHU Dijon
    • Contact: Ludwig Serge AHO-GLELE, Professor; Phone Number: +33 3 80 29 38 01; Email: ludwig.aho@chu-dijon.fr
    • Principal Investigator: Ludwig Serge AHO-GLELE, professor
  • Lyon, France, 69003
    • Recruiting
    • Edouard Herriot Hospital
    • Contact: Philippe VANHEMS, Professor; Phone Number: +33 4 72 11 07 20; Email: Philippe.vanhems@chu-lyon.fr
    • Principal Investigator: Philippe VANHEMS, Professor
  • Paris, France, 75877
    • Not yet recruiting
    • Bichat hospital
    • Contact: Solen KERNEIS, Professor; Phone Number: +33 1 40 25 60 59; Email: solen.kerneis@aphp.fr
    • Principal Investigator: Solen KERNEIS, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults> 18 years old
• 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:

• Pregnant, parturient or breastfeeding women
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Biological: 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.; Other: Questionnaire; questionnaire including demographic data, data on medical history and vaccination, and clinical and biological data on the viral episode.
Other: 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	Biological: 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.; Other: Questionnaire; questionnaire including demographic data, data on medical history and vaccination, and clinical and biological data on the viral episode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hospital-acquired respiratory viral infections	The primary endpoint will be evaluated by calculating the incidence of hospital-acquired respiratory viral infections overall and by type of virus (influenza, COVID-19, RSV) during the surveillance period. incidence rate will be estimated by the ration of number of incident cases over the study period to the cumulative observation time (in person-weeks) of hospitalized patients. Incidence density will be estimated by the ratio of number of incident cases during successive weekly observation periods to the cumulative observation times calculated over the same periods.	At inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2024
• Primary Completion (Estimated): July 5, 2026
• Study Completion (Estimated): July 5, 2026

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Influenza; COVID-19; France; Hospital-acquired infection; SRV
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease; Infections; Communicable Diseases; Cross Infection
• Other Study ID Numbers: 69HCL23_1091; 2024-A01267-40 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No