Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respiratory syndrome cohort | Patients entering fever clinics, emergency departments, outpatient clinics, or inpatient wards who meet the respiratory syndrome screening and diagnostic criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiered pathogen testing and multi-omics analysis | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate and pathogen spectrum of respiratory syndrome pathogens among enrolled participants | 3 years | |
| Immune response and antibody levels after respiratory syndrome-related infection or vaccination | 3 years |
Not provided
Not provided
Inclusion Criteria:
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."
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients with respiratory syndrome treated in fever clinics, emergency departments, outpatient clinics, or inpatient wards of participating medical institutions across China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingwen Ai, M.D. | Contact | +86 17317958269 | jingwenai@fudan.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing You'an Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100069 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Nasopharyngeal and/or oropharyngeal swabs, sputum, clinically remaining bronchoalveolar lavage fluid, stool, urine, peripheral blood, and other clinically remaining samples when applicable will be used for pathogen detection, sequencing, antibody testing, cytokine testing, and exploratory multi-omics analyses.
|
| The Fifth Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510700 | China |
|
| The Fifth Affiliated Hospital of Sun Yat-sen University | Recruiting | Zhuhai | Guangdong | 519000 | China |
|
| The 980th Hospital of the People's Liberation Army Joint Logistics Support Force | Recruiting | Shijiazhuang | Hebei | 050082 | China |
|
| Heilongjiang Provincial Hospital | Recruiting | Harbin | Heilongjiang | 150036 | China |
|
| Jiamusi Central Hospital | Recruiting | Jiamusi | Heilongjiang | 154002 | China |
|
| Shangqiu Municipal Hospital | Recruiting | Shangqiu | Henan | 476000 | China |
|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
|
| Yichang Third People's Hospital | Recruiting | Yichang | Hubei | 443003 | China |
|
| Hunan University of Medicine General Hospital | Recruiting | Huaihua | Hunan | 418000 | China |
|
| The Third Hospital of Baotou (Baotou City Hospital for Infectious Diseases) | Recruiting | Baotou | Inner Mongolia | 014040 | China |
|
| Nanjing Hospital of Chinese Medicine | Recruiting | Nanjing | Jiangsu | 210022 | China |
|
| The Third People's Hospital of Nantong (Nantong Hospital of Infectious Diseases) | Recruiting | Nantong | Jiangsu | 226006 | China |
|
| Wuxi Fifth People's Hospital | Recruiting | Wuxi | Jiangsu | 214005 | China |
|
| Jiujiang No.1 People's Hospital | Recruiting | Jiujiang | Jiangxi | 332000 | China |
|
| Shenyang Sixth People's Hospital | Recruiting | Shenyang | Liaoning | 110006 | China |
|
| Affiliated Hospital of Yan'an University | Recruiting | Yan’an | Shaanxi | 716000 | China |
|
| Zaozhuang Municipal Hospital | Recruiting | Zaozhuang | Shandong | 277100 | China |
|
| Huashan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
|
| Shanghai East Hospital | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
|
| Jinyang Community Health Service Center of Pudong New Area, Shanghai | Recruiting | Shanghai | Shanghai Municipality | 200136 | China |
|
| Shanghai Sixth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200233 | China |
|
| Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center | Recruiting | Shanghai | Shanghai Municipality | 201399 | China |
|
| First Hospital of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | 030001 | China |
|
| Children's Hospital of Shanxi Province | Recruiting | Taiyuan | Shanxi | 030013 | China |
|
| Characteristic Medical Center of Chinese People's Armed Police Force | Recruiting | Tianjin | Tianjin Municipality | 300162 | China |
|
| Altay Prefecture People's Hospital, Xinjiang | Recruiting | Altay | Xinjiang | 836500 | China |
|
| Changji Hui Autonomous Prefecture People's Hospital | Recruiting | Changji | Xinjiang | 831100 | China |
|
| The First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang | 830054 | China |
|
| Hekou Yao Autonomous County People's Hospital | Recruiting | Hekou | Yunnan | 661399 | China |
|
| The First People's Hospital of Yunnan Province | Recruiting | Kunming | Yunnan | 650032 | China |
|
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided