About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Male or female adults aged ≥50 years (calculated based on date of birth and date of visit).
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.
Disqualifiers
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.
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
NP swabs
Diagnostic testNasopharyngeal (NP) swabs will be collected from all participants for respiratory pathogen detection using point-of-care testing (POCT) and/or centralized laboratory analysis.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
Other outcomes
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.
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.
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.
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.
Sponsors and contacts
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Huashan Hospital
Lead sponsor
Shanghai Huashen Institute of Microbes and Infections
Collaborator
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