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

— Observational Acute Respiratory Infections (ARIs)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NP swabs.
Who it may be relevant to
Registry conditions: Acute Respiratory Infections (ARIs). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

RSV in Acute Respiratory Infection Surveillance Among Community-Dwelling Elderly Aged ≥50 Years in China: A Prospective, Observational, Community-Based Study

Overview

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 test 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.

Primary outcome measures

  • Incidence rate of RSV [Time frame: From September 2025 to September 2027]
Secondary outcome measures (3)
  • Positive rate of RSV [Time frame: From September 2025 to September 2027.]
  • Prevalence [Time frame: From September 2025 to September 2027.]
  • Association between symptoms and pathogens [Time frame: From enrollment to the final sample collection on Day 7.]

Eligibility criteria

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 :
  • 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.
  • CAI group:
  • In the household, include at least one patient meeting the inclusion criteria (index case\[s\]) of CRE-ARI group.
  • Male or female adults aged ≥50 years or children aged<5 years (calculated based on date of birth and date of visit).
  • 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.
  • Provision of written informed consent by the participant or their legal guardian, in accordance with local EC (Ethics Committee) requirements.

Exclusion criteria

  • 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.
  • Unwilling to provide consent/assent (if applicable) to participate.
  • Unwilling to provide biological samples.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 13 centers
  • The First Affiliated Hospital of Xiamen University — Xiamen
  • The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai
  • Affiliated Hospital of Zunyi Medical University — Zunyi
  • The First Affiliated Hospital of Xinxiang Medical University — Xinxiang
  • The Third People's Hospital of Yichang — Yichang
  • Nanjing Municipal Hospital of Traditional Chinese Medicine — Nanjing
  • First People's Hospital of Jiujiang — Jiujiang
  • The Sixth People's Hospital of Shenyang — Shenyang
  • … and 5 more centers

Identifiers

NCT: NCT07075029 · RAISE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗