NP swabs: Nasopharyngeal (NP) swabs will be collected from all participants for respiratory pathogen detection using point-of-care testing (POCT) and/or centralized laboratory analysis.
Study summary
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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* CRE-ARI group:
1. Male or female adults aged ≥50 years (calculated based on date of birth and date of visit).
2. 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
3. Provision of written informed consent by the participant or their legal guardian, in accordance with local EC (Ethics Committee) requirements.
* CAI group:
1. In the household, include at least one patient meeting the inclusion criteria (index case\[s\]) of CRE-ARI group.
2. Male or female adults aged ≥50 years or children aged\<5 years (calculated based on date of birth and date of visit).
3. 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.
4. Provision of written informed consent by the participant or their legal guardian, in accordance with local EC (Ethics Committee) requirements.
Exclusion Criteria:
1. Enrollment in the CRE-ARI group within the preceding 14 days.
2. 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).
3. For CAI group, if a household has been enrolled into CAI group within the previous 12 months.
4. Residence outside the designated study catchment area.
5. Unwilling to provide consent/assent (if applicable) to participate.
6. Unwilling to provide biological samples.
7. 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.
Primary outcome measure(s)
Incidence rate of RSV — 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.
Trial sites (13)
Facility
City
Region
Status
The First Affiliated Hospital of Xiamen University
Xiamen
Fujian
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai
Guangdong
Affiliated Hospital of Zunyi Medical University
Zunyi
Guizhou
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang
Henan
The Third People's Hospital of Yichang
Yichang
Hubei
Nanjing Municipal Hospital of Traditional Chinese Medicine
Nanjing
Jiangsu
First People's Hospital of Jiujiang
Jiujiang
Jiangxi
The Sixth People's Hospital of Shenyang
Shenyang
Liaoning
Zaozhuang Municipal Hospital
Zaozhuang
Shandong
The First Hospital of Shanxi Medical University
Taiyuan
Shanxi
Affiliated Hospital of Yan'an University
Yanan
Shanxi
Baihe Town Community Health Service Center
Shanghai
China
Chinese People's Armed Police Force Characteristic Medical Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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