REspiratory Syncytial Virus Consortium in EUrope (RESCEU) Study: Defining the Burden of Disease of Respiratory Syncytial Virus in Older Adults in Europe.
试验速览
- 阶段
- 不适用
- 发起方
- UMC Utrecht
- 入组人数
- 1,040
- 试验地点
- 3
- 主要终点
- Number of participants with a Reverse Transcription-Polymerase Chain Reaction (RT-PCR) confirmed RSV infection (incidence of RSV infection).
研究概览
简要总结
The REspiratory Syncytial virus Consortium in EUrope (RESCEU) is an Innovative Medicine Initiative (IMI) funded by the EU under the H2020 framework to define and understand the burden of disease caused by human respiratory syncytial virus (RSV) infection. RSV causes severe disease in individuals at the extremes of the age spectrum and in high risk groups. It was estimated that RSV was associated with 34 million cases of acute respiratory tract infection (ARTI), 3.4 million ARTI hospitalizations and 55,000 to 199,000 deaths in children <5 years in 2005 worldwide. The estimated burden of disease in older adults is comparable with non-pandemic influenza A (for which a vaccine is available). These estimates were based on limited data and there is a substantial gap in knowledge on morbidity and associated healthcare and social costs in Europe. New vaccines and therapeutics against RSV are in development and could soon be available on the European market. RESCEU will deliver knowledge of the incidence and burden of RSV disease in young children and older adults in Europe, which is essential for stakeholders (governments, etc.) to take decisions about prophylaxis and treatment.
Objective:
To determine the burden of disease due to RSV in older adults.
Study design:
Prospective epidemiological, observational, multi-country, multicenter cohort study.
Study population:
Adults aged 60 years and up (n=1,000) of which approximately 50% is above 75 years of age.
Main study parameters/endpoints:
The primary endpoints of the study are;
- The incidence of RSV infection-associated ARTI.
- RSV associated medically attended (MA) ARTI.
- RSV related hospitalization.
详细描述
In total, 1000 participants are recruited in three European countries (the Netherlands, Belgium and the United Kingdom). Participants, older adults above the age of 60 years, are recruited from general practitioners offices. Individual participants will be followed for one year (at least one winter season). For the individual participant the study procedures are described below:
Baseline visit:
Baseline visits are performed either at home or at the participating site before the start of the RSV season. The beginning of the season is to be determined per site in accordance to the local virologic surveillance reports. In general, baseline visits are performed between August and the beginning of October.
A questionnaire on demographic, social and clinical status is completed during this visit. Additionally, vital signs are recorded such as oxygen saturation, heart frequency and breathing frequency. During the baseline visit a blood sample (60 ml, serum, paxgene, whole blood) and nasopharyngeal swab (microbiome) will be collected.
Weekly follow-up during the RSV season:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female adults ≥60 years of age (comorbidity, including chronic heart disease is not an exclusion criterion)
- •Willing and able to give written informed consent
- •Willing and able to adhere to protocol-specified procedures
排除标准
- •Unable to perform the study procedures
- •Current alcohol or drug abuse or history of unsuccessfully treated alcohol or drug abuse within the past year
- •Life expectancy less than 1 year
- •Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination (a more detailed description/list can be found in appendix 3 of the study protocol).
- •Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to study participation. The use of topical, inhaled, and nasal glucocorticoids will be permitted (a more detailed description/list can be found in appendix 3 of the study protocol).
- •Previous participation in this study or in a RSV interventional trial (vaccine, antivirals).
- •Planned leave/holiday during the winter season of more than 1 month in total.
结局指标
主要结局
Number of participants with a Reverse Transcription-Polymerase Chain Reaction (RT-PCR) confirmed RSV infection (incidence of RSV infection).
时间窗: Data is collected during the RSV season by weekly contact and viral swab diagnostics for RSV in case of respiratory infection. Medically attended RSV will be recorded throughout the one year follow-up.
The main outcome of the study is to determine the burden of RSV in the older adult population. Therefore the incidence rate of all RSV in the overall study population of older patients is investigated, including medically attended RSV infection-associated ARTI in both inpatients and outpatients. Nasal swabs are collected by the study team in case of a respiratory infection and tested with RT-PCR for presence of RSV. The incidence of RSV is calculated by dividing the number of RSV positive infections by the total number of study participants. The number of RSV positive infections divided by the total number of infections is calculated as well.
次要结局
- RSV-related mortality through the RSV season.(Data on mortality is collected during individual study participation of 1 year)
- The incidence rate of RSV-associated secondary bacterial pneumonia events(Data on the incidence of pneumonia are collected during individual study participation of 1 year)
- The incidence rate of all-cause MA-ARTI or events leading to worsening of cardiorespiratory status (based on questionnaires at baseline and after one year of follow-up).(Data on worsening of cardiorespiratory status is collected during individual study participation of 1 year)
- Non-RSV related mortality through the RSV season.(Data on mortality is collected during individual study participation of 1 year)
- Health care costs for RSV-associated ARTI.(Data on health care costs are collected during individual study participation of 1 year)
- Health care costs for all-cause MA-ARTI.(Data on health care costs are collected during individual study participation of 1 year)
- Change in frailty over the course of study using the Groningen Frailty indicator (GFI) questionnaire.(Data on the change in frailty is collected during individual study participation of 1 year)
- Sample collection for biomarker analysis to investigate possible biomarkers which are predictive of severe or complicated RSV disease in older adults(Samples are collected at various timepoints during the one year study participation.)