Acute Respiratory Infections (ARIs)RAISENCT07075029
RSV in Acute Respiratory Infection Surveillance Among Community-Dwelling Elderly Aged ≥50 Years in China
An observational study of Acute Respiratory Infections (ARIs), run by Huashan Hospital at 13 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Infections (ARIs)
- What is being tested?
- NP swabs
- How many people
- 28,800 participants
- Where
- 13 sitesChina
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites
First People's Hospital of Jiujiang
Jiujiang, Jiangxi
Xiaoming Xiong, xiongxiaoming26@163.com
Nanjing Municipal Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu
Yanliang Zhang, fsyy00404@njucm.edu.cn
Baihe Town Community Health Service Center
Shanghai
Wei Wang
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning
Hongyan Liu, lnhyliu@sina.com
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Liaoyun Zhang, zlyylzy@163.com
Chinese People's Armed Police Force Characteristic Medical Center
Tianjing
Bin Liu
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Jiabian Lian, faster_lian@xmu.edu.cn
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan
Daokun Yang
Affiliated Hospital of Yan'an University
Yanan, Shanxi
Xiaohong Gao, 13891118887@163.com
The Third People's Hospital of Yichang
Yichang, Hubei
Zhu Jin
Zaozhuang Municipal Hospital
Zaozhuang, Shandong
Min Dong
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong
Xi Liu, liuxi26@mail.sysu.edu.cn
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou
Yuanbo Lan
About this study
Official title: RSV in Acute Respiratory Infection Surveillance Among Community-Dwelling Elderly Aged ≥50 Years in China: A Prospective, Observational, Community-Based Study
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.
Read the detailed description
The study will cover about 10 communities representing diverse geographical locations, economic conditions, and population densities.
- Conditions
- Acute Respiratory Infections (ARIs)
- Being tested
- NP swabs
- Keywords
- RSV, Acute Respiratory Infections, Community
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP swabsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: NP swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From September 2025 to September 2027
Secondary outcomes (3)
Positive rate of RSV
To investigate the positive rate of RSV in the community-dwelling adults of 50 years or older with ARI in China.
Measured: From September 2025 to September 2027.
Prevalence
To investigate the prevalence of common upper respiratory system infection pathogens in community-dwelling adults aged 50 years or older with ARI in China.
Measured: From September 2025 to September 2027.
Association between symptoms and pathogens
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.
Measured: From enrollment to the final sample collection on Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Infections (ARIs)Studies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Huashen Institute of Microbes and Infections
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenhong Zhang, MD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075029
- Sponsor's protocol ID
- RAISE
- Acronym
- RAISE
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After thesis defense the study may be published internationally to be available for the public.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RSV in Acute Respiratory Infection Surveillance Among Community-Dwelling Elderly Aged ≥50 Years in China: A Prospective, Observational, Community-Based Study
- ClinicalTrials.gov ID
- NCT07075029
- Acronym / sponsor ID
- RAISE / RAISE
- Conditions
- Acute Respiratory Infections (ARIs)
- Keywords
- RSV, Acute Respiratory Infections, Community
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 28,800 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Huashen Institute of Microbes and Infections
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRE-ARI group | – | Diagnostic Test: NP swabsCRE-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. |
| CAI group | – | Diagnostic Test: NP swabsCohabitants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- CRE-ARI group:
- CAI group:
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NP swabsNasopharyngeal (NP) swabs will be collected from all participants for respiratory pathogen detection using point-of-care testing (POCT) and/or centralized laboratory analysis. | Diagnostic test | CAI group, CRE-ARI group |
Primary outcome
Incidence rate of RSV
Time frame: 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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: Undecided. After thesis defense the study may be published internationally to be available for the public.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenhong Zhang, MD principal investigator
Huashan Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Infections (ARIs), run by Huashan Hospital at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingwen Ai, M.D. (+86 13764990804, jingwenai@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of RSV (time frame: From September 2025 to September 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.