Hospital-acquired Respiratory Viral Infection: A Prospective Multicenter Study in France
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Incidence of hospital-acquired respiratory viral infections
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Nasopharyngeal swab (Biological)
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.
干预措施: Questionnaire (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
干预措施: Nasopharyngeal swab (Biological)
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
干预措施: Questionnaire (Other)
结局指标
主要结局
Incidence of hospital-acquired respiratory viral infections
时间窗: At inclusion
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.
次要结局
未报告次要终点