Respiratory Tract Infections (RTI)NCT07694648
Clinical Multimodal Surveillance of Respiratory Syndrome Pathogens
An observational study of Respiratory Tract Infections (RTI) and Respiratory Syndrome, Acute, Severe, run by Huashan Hospital at 31 sites in China.
Trial summary
This nationwide, multicenter observational study will establish and improve a hospital-based clinical surveillance and early warning system for respiratory syndrome pathogens. Clinical data and biospecimens generated during routine care will be collected from participating medical institutions every two weeks to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Tract Infections (RTI), Respiratory Syndrome, Acute, Severe, Acute Respiratory Infections (ARIs)
- What is being tested?
- Tiered pathogen testing and multi-omics analysis
- How many people
- 2,398 participants
- Where
- 31 sitesChina
- Study dates
- 1 Sep 2025to 30 Sep 2028
- Phase
- Observational
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with respiratory syndrome treated in fever clinics, emergency departments, outpatient clinics, or inpatient wards of participating medical institutions across China.
Who may be able to join
- Patients with respiratory syndrome: Eligible patients are those diagnosed with respiratory syndrome based on the predefined data dictionary and the following ICD-10 (International Statistical Classification of Diseases, 10th Revision) diagnosis codes: R05, R50, J00, J01, J02, J03, J04, J06, J07, J08, J09, J10, J11, J12, J13, J14, J15, J16, J17, J18, J20, J21, J98.414, and J98.802.
- Patients with respiratory syndrome: Eligible patients are identified using the following search criteria. Patients meeting any one of the following criteria should be included:
- Medical history (History of Present Illness): Positive test result for a respiratory syndrome-related pathogen.
- Laboratory testing: Positive test result for a respiratory syndrome-related pathogen.
- Medication: Receipt of any of the following antiviral agents:
- Nirmatrelvir/Ritonavir Leritrelvir Xiannuotewei/Ritonavir Molnupiravir Azvudine Deuremidevir
- Diagnosis: Diagnosis containing the term "respiratory tract infection."
Who cannot join
- Participants who may compromise the study results: Patients who are unable to provide a specimen or whose specimen volume is insufficient for laboratory testing.
- Participants who are unable to comply with study procedures.
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
China31 sites, 31 recruiting
- Recruiting
Altay Prefecture People's Hospital, Xinjiang
Altay, Xinjiang, 836500
Xiaofeng Wang, +86 18999799159, 1065562125@qq.com
- Recruiting
The Third Hospital of Baotou (Baotou City Hospital for Infectious Diseases)
Baotou, Inner Mongolia, 014040
Xingyan Yao, +86 15024783159, 15024783159@163.com
- Recruiting
Beijing You'an Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
Jiaying Zhang, +86 13810146575, jiayingyahoo@163.com
- Recruiting
Changji Hui Autonomous Prefecture People's Hospital
Changji, Xinjiang, 831100
Jiangtao Liu, +86 13689925010, 44562105@qq.com
- Recruiting
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510700
Shi Ouyang, +86 18928779890, Ouyangshi@gzhmu.edu.cn
- Recruiting
Heilongjiang Provincial Hospital
Harbin, Heilongjiang, 150036
Xiaoli Hu, +86 15804610988, huxiaoli1976@163.com
- Recruiting
Hekou Yao Autonomous County People's Hospital
Hekou, Yunnan, 661399
Hao Liu, +86 13529806826, 692004016@qq.com
- Recruiting
Hunan University of Medicine General Hospital
Huaihua, Hunan, 418000
Yongzhong Li, +86 15096257715, liyz2008@163.com
- Recruiting
Jiamusi Central Hospital
Jiamusi, Heilongjiang, 154002
Limei Zheng, +86 18745467889, zlm1970@126.com
- Recruiting
Jiujiang No.1 People's Hospital
Jiujiang, Jiangxi, 332000
Xiaoming Xiong, +86 15179207648, xiongxiaoming26@163.com
- Recruiting
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032
Jiawei Geng, +86 13888757766, Jiawei-Geng@kmust.edu.cn
- Recruiting
Nanjing Hospital of Chinese Medicine
Nanjing, Jiangsu, 210022
Yanliang Zhang, +86 13815440366, fsyy00404@njucm.edu.cn
- Recruiting
The Third People's Hospital of Nantong (Nantong Hospital of Infectious Diseases)
Nantong, Jiangsu, 226006
Meihua Wang, +86 13962958843, wmh85834876@163.com
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Jingwen Ai, M.D., +86 17317958269, jingwenai@fudan.edu.cn
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Lihong Qu, +86 18916510601, 18916510601@163.com
- Recruiting
Jinyang Community Health Service Center of Pudong New Area, Shanghai
Shanghai, Shanghai Municipality, 200136
Wei Song, +86 13651768797, 13651768797@163.com
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Xiaohua Chen, +86 18930177207, chenxiaohua2000@163.com
- Recruiting
Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
Shanghai, Shanghai Municipality, 201399
Yao Shen, +86 18918361707, 13611692261@163.com
- Recruiting
Shangqiu Municipal Hospital
Shangqiu, Henan, 476000
Wenliang Zhou, +86 15037069103, 280514093@qq.com
- Recruiting
Shenyang Sixth People's Hospital
Shenyang, Liaoning, 110006
Hongyan Liu, +86 18502460070, lnhyliu@sina.com
- Recruiting
The 980th Hospital of the People's Liberation Army Joint Logistics Support Force
Shijiazhuang, Hebei, 050082
Junping Wang, +86 13931130982, wjp9810@163.com
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Liaoyun Zhang, +86 13603518852, zlysgzy@163.com
- Recruiting
Children's Hospital of Shanxi Province
Taiyuan, Shanxi, 030013
Xianghong Zhou, +86 18035128106, 3095753120@qq.com
- Recruiting
Characteristic Medical Center of Chinese People's Armed Police Force
Tianjin, Tianjin Municipality, 300162
Bin Liu, +86 13752575109, iamicehe@163.com
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Xiaobo Lu, +86 15999176213, xjykdluxiaobo@126.com
- Recruiting
Wuxi Fifth People's Hospital
Wuxi, Jiangsu, 214005
Yuanwang Qiu, +86 13656187282, qywang839@126.com
- Recruiting
Affiliated Hospital of Yan'an University
Yan’an, Shaanxi, 716000
Xiaohong Gao, +86 13891118887, 13891118887@163.com
- Recruiting
Yichang Third People's Hospital
Yichang, Hubei, 443003
Zhu Jin, +86 13308608938 ext. 18654108@qq.co
- Recruiting
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, 277100
Min Dong, +86 18266080118, zz919816@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Zujiang Yu, +86 18603710022, fcclij2@zzu.edu.cn
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
Xi Liu, +86 15992670630, liuxi26@mail.sysu.edu.cn
About this study
Official title: Clinical Multimodal Early Warning Surveillance of Respiratory Syndrome Pathogens and Construction and Application of Prevention and Control Measures
This nationwide, multicenter observational study will establish and improve a hospital-based clinical surveillance and early warning system for respiratory syndrome pathogens. Clinical data and biospecimens generated during routine care will be collected from participating medical institutions every two weeks to monitor pathogen trends, support risk assessment, and provide evidence for prevention and control measures.
Read the detailed description
This study will enroll eligible patients with respiratory syndrome from fever clinics, emergency departments, outpatient clinics, and inpatient wards in participating hospitals across seven administrative regions in China. Standardized clinical data, including demographic information, symptoms, diagnoses, laboratory tests, medication orders, oxygen therapy, hospitalization, ICU admission, and outcomes, will be reported through encrypted data channels every two weeks. For eligible participants meeting the tiered diagnostic criteria, respiratory samples and clinically remaining biospecimens will be tested using routine pathogen testing, multiplex PCR or targeted sequencing, metagenomic next-generation sequencing, antibody testing, cytokine testing, and exploratory multi-omics assays as clinically appropriate. The study aims to generate national and regional surveillance reports and support early warning, pathogen identification, and prevention and control strategies.
- Conditions
- Respiratory Tract Infections (RTI), Respiratory Syndrome, Acute, Severe, Acute Respiratory Infections (ARIs)
- Being tested
- Tiered pathogen testing and multi-omics analysis
- Keywords
- Respiratory syndrome, respiratory pathogens, clinical surveillance, early warning, multiplex PCR, metagenomic next-generation sequencing, multi-omics, nationwide multicenter study
- Medical subject headings
- Respiratory Tract Infections, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiered pathogen testing and multi-omics analysisDiagnostic test
Participants will undergo clinically indicated tiered testing, including SARS-CoV-2 nucleic acid testing, influenza A/B antigen or nucleic acid testing, routine blood testing, targeted sequencing or multiplex PCR, metagenomic next-generation sequencing, respiratory pathogen antibody testing, cytokine testing, and exploratory transcriptomics, metabolomics, proteomics, single-cell, microbiome, and related analyses using collected or clinically remaining samples.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory syndrome cohort | Patients entering fever clinics, emergency departments, outpatient clinics, or inpatient wards who meet the respiratory syndrome screening and diagnostic criteria. Receives: Diagnostic Test: Tiered pathogen testing and multi-omics analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate and pathogen spectrum of respiratory syndrome pathogens among enrolled participants
Measured: 3 years
Immune response and antibody levels after respiratory syndrome-related infection or vaccination
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Sep 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract Infections (RTI)Studies of the same condition, open and under way.
- 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
- 2,398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingwen Ai, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694648
- Sponsor's protocol ID
- KY2025-1002
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided