| NCT ID | NCT06643039 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Nosocomial Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-12-05 |
| Primary Completion | 2026-07-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2024-12-05 with a primary completion date of 2026-07-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06643039 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nosocomial Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06643039 currently recruiting?
Yes, NCT06643039 is actively recruiting participants. Contact the research team at Philippe.vanhems@chu-lyon.fr for enrollment information.
Where is the NCT06643039 trial being conducted?
This trial is being conducted at Bordeaux, France, Dijon, France, Lyon, France, Paris, France.
Who is sponsoring the NCT06643039 clinical trial?
NCT06643039 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 1,000 participants.