Nosocomial InfectionsNOSOVIRUSNCT06643039
Nosocomial Respiratory Virus Infection
A study testing Nasopharyngeal swab and Questionnaire in people with Nosocomial Infections, run by Hospices Civils de Lyon at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nosocomial Infections
- What is being tested?
- Nasopharyngeal swab and Questionnaire
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 6 sitesFrance
- Study dates
- 5 Dec 2024to 5 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Not yet recruiting
Pellegrin Hospital
Bordeaux, 33076
Anne Marie ROGUES, Professor, +33 5 56 79 55 53, anne-marie.rogues@chu-bordeaux.fr
Anne Marie ROGUES, Professor
- Not yet recruiting
CHU Dijon
Dijon, 21079
Ludwig Serge AHO-GLELE, Professor, +33 3 80 29 38 01, ludwig.aho@chu-dijon.fr
Ludwig Serge AHO-GLELE, professor
- Recruiting
Edouard Herriot Hospital
Lyon, 69003
Philippe VANHEMS, Professor, +33 4 72 11 07 20, Philippe.vanhems@chu-lyon.fr
Philippe VANHEMS, Professor
- Not yet recruiting
Saint Louis Hospital
Paris, 75010
Guillaume MELLON, Dr, 01 42 49 44 97, guillaume.mellon@aphp.fr
- Not yet recruiting
Bichat Hospital
Paris, 75877
Solen KERNEIS, Professor, +33 1 40 25 60 59, solen.kerneis@aphp.fr
Solen KERNEIS, professor
- Not yet recruiting
Saint Louis Hospital
Paris
Nathalie DE CASTRO, Dr, 01 42 49 48 20, nathalie.de-castro@aphp.fr
About this study
Official title: 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.
Read more
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
- Nosocomial Infections
- Being tested
- Nasopharyngeal swab, Questionnaire
- Keywords
- Hospital-acquired infection, COVID-19, Influenza, SRV, France
- Medical subject headings
- Cross Infection, COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal swabBiological
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.
QuestionnaireOther
questionnaire including demographic data, data on medical history and vaccination, and clinical and biological data on the viral episode.
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized in participating services for more than 24h | Other | 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. Receives: Biological: Nasopharyngeal swab; Other: Questionnaire |
| Volunteered health care professionals | Other | 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 Receives: Biological: Nasopharyngeal swab; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start5 Dec 2024
- Primary completion5 Jul 2027 (estimated)
- Study completion5 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial InfectionsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643039
- Sponsor's protocol ID
- 69HCL23_1091
- Other IDs
- 2024-A01267-40
- Acronym
- NOSOVIRUS
- Status last verified
- Sep 2026
- First submitted
- 14 Oct 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No