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

NCT07075029 | Not Yet Recruiting

• 1 other identifier: RAISE
• Study Type: observational
• Target: 28,800
• Locations: 1 country
• Sites: 13

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.

Conditions

Acute Respiratory Infections (ARIs)

Keywords

RSV; Acute Respiratory Infections; Community

Outcome Measures

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.

  From September 2025 to September 2027

Secondary Outcomes (3)

• Positive rate of RSV

  From September 2025 to September 2027.

• Prevalence

  From September 2025 to September 2027.

• Association between symptoms and pathogens

  From enrollment to the final sample collection on Day 7.

Other Outcomes (5)

• Assessment of risk and protective factors for RSV infection through questionnaires

  From September 2025 to September 2027.

• Association between symptoms and pathogens in high risk household members

  From enrollment to the final sample collection on Day 7.

• Prevalence

  From September 2025 to September 2027.

Study Arms (2)

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.

Diagnostic Test: NP swabs

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.

Diagnostic Test: NP swabs

Interventions

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.

CAI group; CRE-ARI group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead
• Shanghai Huashen Institute of Microbes and Infections: collaborator

Study Sites (13)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Location

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Location

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Location

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Location

The Third People's Hospital of Yichang

Yichang, Hubei, China

Location

Nanjing Municipal Hospital of Traditional Chinese Medicine

Nanjing, Jiangsu, China

Location

First People's Hospital of Jiujiang

Jiujiang, Jiangxi, China

Location

The Sixth People's Hospital of Shenyang

Shenyang, Liaoning, China

Location

Zaozhuang Municipal Hospital

Zaozhuang, Shandong, China

Location

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Affiliated Hospital of Yan'an University

Yanan, Shanxi, China

Location

Baihe Town Community Health Service Center

Shanghai, China

Location

Chinese People's Armed Police Force Characteristic Medical Center

Tianjing, China

Location

Study Officials

• Wenhong Zhang, MD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingwen Ai, M.D.

CONTACT

+86 13764990804; jingwenai@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Division of Infectious Diseases Affiliation, Huashan Hospital; Shanghai Huashen Institute of Microbes and Infections

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

CN (13)