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

Not yet recruiting

• Conditions: Acute Respiratory Infections (ARIs)

• Registration Number: NCT07075029
• Lead Sponsor: Huashan Hospital

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20
• Study Start: 2025-09-01
• Primary Completion: 2027-11-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28800

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

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

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