RSV in Acute Respiratory Infection Surveillance Among Community-Dwelling Elderly Aged ≥50 Years in China

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHuashan Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

28,800 Participants
are divided into 2 treatment groups
Group A: CRE-ARI group1 intervention
Group B: CAI group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From September 2025 to September 2027

Secondary outcomes

1

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.

Time frame
From September 2025 to September 2027.
2

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.

Time frame
From September 2025 to September 2027.
3

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.

Time frame
From enrollment to the final sample collection on Day 7.

Other outcomes

1

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.

Time frame
From September 2025 to September 2027.
2

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.

Time frame
From enrollment to the final sample collection on Day 7.
3

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.

Time frame
From September 2025 to September 2027.
4

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.

Time frame
From enrollment to the final sample collection on Day 7.

Sponsors and contacts

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Huashan Hospital

Lead sponsor

Shanghai Huashen Institute of Microbes and Infections

Collaborator

This trial is not recruiting at the moment. You can still explore other options: