Acute Respiratory Infections (ARIs)
Conditions
Keywords
RSV, Acute Respiratory Infections, Community
Brief 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.
Detailed description
The study will cover about 10 communities representing diverse geographical locations, economic conditions, and population densities.
Interventions
DIAGNOSTIC_TESTNP 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.
Sponsors
Shanghai Huashen Institute of Microbes and Infections
Huashan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive rate of RSV | From September 2025 to September 2027. | To investigate the positive rate of RSV in the community-dwelling adults of 50 years or older with ARI in China. |
| Prevalence | From September 2025 to September 2027. | 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 | From enrollment to the final sample collection on Day 7. | 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of risk and protective factors for RSV infection through questionnaires | From September 2025 to September 2027. | 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. |
| Transmission of RSV | From enrollment to the final sample collection on Day 7. | 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. |
| Association between symptoms and pathogens in high risk household members | From enrollment to the final sample collection on Day 7. | 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 | From September 2025 to September 2027. | 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 | From enrollment to the final sample collection on Day 7. | 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. |
Countries
China
Contacts
Primary ContactJingwen Ai, M.D.
Outcome results
None listed