RSV in Acute Respiratory Infection Surveillance Among Community-Dwelling Elderly Aged ≥50 Years in China: A Prospective, Observational, Community-Based Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28,800
- 试验地点
- 13
- 主要终点
- Incidence rate of RSV
研究概览
简要总结
This is a multicenter, prospective, observational, community-based study designed to evaluate the incidence of respiratory syncytial virus (RSV) infection among community-dwelling elderly individuals in China, as well as their cohabiting older adults and children, over a 24-month period. During the study, home visits will be conducted to collect nasopharyngeal (NP) swabs from all community residents aged ≥50 years who report symptoms of acute respiratory infection (ARI). Pathogen detection will be performed using both point-of-care testing (POCT) and centralized laboratory analysis.
详细描述
The study will cover about 10 communities representing diverse geographical locations, economic conditions, and population densities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CRE-ARI group:
- •Male or female adults aged ≥50 years (calculated based on date of birth and date of visit).
- •Presence one of the following conditions of ARI case definition :
- •At least two respiratory symptoms/signs within 48 hours prior to self-reporting OR
- •At least one respiratory symptom/sign + one systemic symptom/sign within 48 hours prior to self-reporting
- •Provision of written informed consent by the participant or their legal guardian, in accordance with local EC (Ethics Committee) requirements.
- •CAI group:
- •In the household, include at least one patient meeting the inclusion criteria (index case[s]) of CRE-ARI group.
- •Male or female adults aged ≥50 years or children aged<5 years (calculated based on date of birth and date of visit).
- •In the household, apart from the index case(s), there are two or more members who meet the criteria (2) AND are willing to participate, regardless of whether these household members exhibit ARI symptoms.
- •Provision of written informed consent by the participant or their legal guardian, in accordance with local EC (Ethics Committee) requirements.
排除标准
- •Enrollment in the CRE-ARI group within the preceding 14 days.
- •Enrollment in the CRE-ARI group has been more than 4 times during the previous 12 months (applicable only to the CRE-ARI group enrollment).
- •For CAI group, if a household has been enrolled into CAI group within the previous 12 months.
- •Residence outside the designated study catchment area.
- •Unwilling to provide consent/assent (if applicable) to participate.
- •Unwilling to provide biological samples.
- •Any other situation deemed inappropriate for participation by the investigator, including potential risks to the subject upon enrollment or factors that may affect the interpretation of study results, such as clinical judgment, safety concerns, or the integrity of the study.
结局指标
主要结局
Incidence rate of RSV
时间窗: From September 2025 to September 2027
To investigate the incidence rate of RSV related acute respiratory infection (ARI) in community-dwelling adults of 50 years or older in China.
次要结局
- Positive rate of RSV(From September 2025 to September 2027.)
- Prevalence(From September 2025 to September 2027.)
- Association between symptoms and pathogens(From enrollment to the final sample collection on Day 7.)
研究者
Wen-hong Zhang
Director of Division of Infectious Diseases Affiliation, Huashan Hospital; Shanghai Huashen Institute of Microbes and Infections
Huashan Hospital