Loading clinical trials...

NOT_YET_RECRUITING

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

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

NCT07075029•Huashan Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

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:
•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.

Locations (13)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

The Third People's Hospital of Yichang

Yichang, Hubei, China

Nanjing Municipal Hospital of Traditional Chinese Medicine

Nanjing, Jiangsu, China

First People's Hospital of Jiujiang

Jiujiang, Jiangxi, China

The Sixth People's Hospital of Shenyang

Shenyang, Liaoning, China

Zaozhuang Municipal Hospital

Zaozhuang, Shandong, China

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Key Dates

Start Date

September 1, 2025

Primary Completion Date

November 30, 2027

Completion Date

December 31, 2027

Last Updated

July 20, 2025

Enrollment

28,800

ESTIMATED participants

Conditions

Acute Respiratory Infections (ARIs)

Interventions

NP swabs

DIAGNOSTIC_TEST

Contacts

Jingwen Ai, M.D.

CONTACT

+86 13764990804 jingwenai@fudan.edu.cn

FebriDx® Pediatric Validation Study

NCT07211997

Acute Respiratory Infections (ARIs)

View study

COMPLETED

FebriDx® Method Comparison Study Protocol

NCT06746259

Acute Respiratory Infections (ARIs)

View study

COMPLETEDNA

Nudging Guideline-concordant Antibiotic Prescribing Using Public Commitments

NCT01767064

Acute Respiratory Infections (ARIs)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

FebriDx® Pediatric Validation Study

FebriDx® Method Comparison Study Protocol

Nudging Guideline-concordant Antibiotic Prescribing Using Public Commitments

Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Pilot Study)