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| Name | Class |
|---|---|
| Shanghai Huashen Institute of Microbes and Infections | UNKNOWN |
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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.
The study will cover about 10 communities representing diverse geographical locations, economic conditions, and population densities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRE-ARI group | CRE-ARI group will includes individuals aged 50 years and older who self-report symptoms of acute respiratory infection (ARI) to the investigators/study personnel during the study period. |
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| CAI group | Cohabitants of individuals with ARI will also be enrolled in the study, forming the Cohabitants of ARI Individuals (CAI) group. Eligible participants in this group include older adults aged ≥50 years and children under 5 years of age. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NP swabs | Diagnostic Test | Nasopharyngeal (NP) swabs will be collected from all participants for respiratory pathogen detection using point-of-care testing (POCT) and/or centralized laboratory analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of RSV | To investigate the incidence rate of RSV related acute respiratory infection (ARI) in community-dwelling adults of 50 years or older in China. | From September 2025 to September 2027 |
| Measure | Description | Time Frame |
|---|---|---|
| Positive rate of RSV | To investigate the positive rate of RSV in the community-dwelling adults of 50 years or older with ARI in China. | From September 2025 to September 2027. |
| Prevalence | To investigate the prevalence of common upper respiratory system infection pathogens in community-dwelling adults aged 50 years or older with ARI in China. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of risk and protective factors for RSV infection through questionnaires | To explore risk and protective factors for RSV infection in community-dwelling adults aged 50 years or older with ARI. Information on potential risk and protective factors, such as smoking status, household size, and out-of-home activity patterns, will be collected through questionnaires. | From September 2025 to September 2027. |
Inclusion Criteria:
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 :
Provision of written informed consent by the participant or their legal guardian, in accordance with local EC (Ethics Committee) requirements.
CAI group:
Exclusion Criteria:
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The study will cover approximately 10 communities. All individuals aged 50 years and older residing in these communities will be considered potential participants. Those who self-report symptoms of acute respiratory infection (ARI) will be enrolled. In addition, if their cohabitants meet the inclusion criteria, they will be enrolled as a family unit.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingwen Ai, M.D. | Contact | +86 13764990804 | jingwenai@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wenhong Zhang, MD | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China |
After thesis defense the study may be published internationally to be available for the public.
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| From September 2025 to September 2027. |
| Association between symptoms and pathogens | To investigate the association between symptoms and pathogens in community-dwelling adults aged 50 years or older with ARIs through questionnaires. Symptoms include respiratory signs and symptoms, such as those related to upper and lower respiratory tract disease (URTD and LRTD), as well as systemic signs and symptoms. | From enrollment to the final sample collection on Day 7. |
| Association between symptoms and pathogens in high risk household members | To explore the association between symptoms and pathogens in high risk household members (age ≥50 years or <5 years) living together with community-dwelling ARI adults of 50 years or older through questionnaires. Symptoms include respiratory signs and symptoms, such as those related to upper and lower respiratory tract disease (URTD and LRTD), as well as systemic signs and symptoms. | From enrollment to the final sample collection on Day 7. |
| Prevalence | To explore the prevalence of common upper respiratory system infection pathogen in high risk household members (age ≥50 years or <5 years) living with community-dwelling ARI adults of 50 years or older. | From September 2025 to September 2027. |
| Healthcare seeking behaviors through questionnaires | To explore healthcare-seeking behaviors among community-dwelling adults aged 50 years or older with ARI through questionnaires. Healthcare-seeking behaviors include whether medical care was sought, adherence to medical advice versus self-medication, and the types of medications used. | From enrollment to the final sample collection on Day 7. |
| Transmission of RSV | To explore RSV transmission among high-risk household members (aged ≥50 years or <5 years) living with community-dwelling ARI adults aged 50 years or older, through analysis of full-length RSV genomes from RSV-positive specimens. Sequencing data will be mapped, and candidate single nucleotide polymorphisms (SNPs) will be identified for further analysis. | From enrollment to the final sample collection on Day 7. |
| The Fifth Affiliated Hospital of Sun Yat-sen University | Zhuhai | Guangdong | China |
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| Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | China |
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| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | China |
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| The Third People's Hospital of Yichang | Yichang | Hubei | China |
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| Nanjing Municipal Hospital of Traditional Chinese Medicine | Nanjing | Jiangsu | China |
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| First People's Hospital of Jiujiang | Jiujiang | Jiangxi | China |
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| The Sixth People's Hospital of Shenyang | Shenyang | Liaoning | China |
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| Zaozhuang Municipal Hospital | Zaozhuang | Shandong | China |
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| The First Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
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| Affiliated Hospital of Yan'an University | Yanan | Shanxi | China |
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| Baihe Town Community Health Service Center | Shanghai | China |
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| Chinese People's Armed Police Force Characteristic Medical Center | Tianjing | China |
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