Clinical Multimodal Surveillance of Respiratory Syndrome Pathogens

July 3, 2026 updated by: Jingwen Ai, Huashan Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100069
        • Recruiting
        • Beijing You'an Hospital, Capital Medical University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510700
        • Recruiting
        • The Fifth Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Zhuhai, Guangdong, China, 519000
        • Recruiting
        • The Fifth Affiliated Hospital of Sun Yat-sen University
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050082
        • Recruiting
        • The 980th Hospital of the People's Liberation Army Joint Logistics Support Force
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150036
        • Recruiting
        • Heilongjiang Provincial Hospital
        • Contact:
      • Jiamusi, Heilongjiang, China, 154002
        • Recruiting
        • Jiamusi Central Hospital
        • Contact:
    • Henan
      • Shangqiu, Henan, China, 476000
        • Recruiting
        • Shangqiu Municipal Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Yichang, Hubei, China, 443003
        • Recruiting
        • Yichang Third People's Hospital
        • Contact:
          • Zhu Jin
          • Phone Number: 18654108@qq.co +86 13308608938
    • Hunan
      • Huaihua, Hunan, China, 418000
        • Recruiting
        • Hunan University of Medicine General Hospital
        • Contact:
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014040
        • Recruiting
        • The Third Hospital of Baotou (Baotou City Hospital for Infectious Diseases)
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210022
        • Recruiting
        • Nanjing Hospital of Chinese Medicine
        • Contact:
      • Nantong, Jiangsu, China, 226006
        • Recruiting
        • The Third People's Hospital of Nantong (Nantong Hospital of Infectious Diseases)
        • Contact:
      • Wuxi, Jiangsu, China, 214005
        • Recruiting
        • Wuxi Fifth People's Hospital
        • Contact:
    • Jiangxi
      • Jiujiang, Jiangxi, China, 332000
        • Recruiting
        • Jiujiang No.1 People's Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110006
        • Recruiting
        • Shenyang Sixth People's Hospital
        • Contact:
    • Shaanxi
      • Yan’an, Shaanxi, China, 716000
        • Recruiting
        • Affiliated Hospital of Yan'an University
        • Contact:
    • Shandong
      • Zaozhuang, Shandong, China, 277100
        • Recruiting
        • Zaozhuang Municipal Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200233
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200120
        • Recruiting
        • Shanghai East Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200040
        • Recruiting
        • Huashan Hospital Fudan University
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200136
        • Recruiting
        • Jinyang Community Health Service Center of Pudong New Area, Shanghai
        • Contact:
      • Shanghai, Shanghai Municipality, China, 201399
        • Recruiting
        • Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • First Hospital of Shanxi Medical University
        • Contact:
      • Taiyuan, Shanxi, China, 030013
        • Recruiting
        • Children's Hospital of Shanxi Province
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300162
        • Recruiting
        • Characteristic Medical Center of Chinese People's Armed Police Force
        • Contact:
    • Xinjiang
      • Altay, Xinjiang, China, 836500
        • Recruiting
        • Altay Prefecture People's Hospital, Xinjiang
        • Contact:
      • Changji, Xinjiang, China, 831100
        • Recruiting
        • Changji Hui Autonomous Prefecture People's Hospital
        • Contact:
      • Ürümqi, Xinjiang, China, 830054
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
    • Yunnan
      • Hekou, Yunnan, China, 661399
        • Recruiting
        • Hekou Yao Autonomous County People's Hospital
        • Contact:
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • The First People's Hospital of Yunnan Province
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with respiratory syndrome treated in fever clinics, emergency departments, outpatient clinics, or inpatient wards of participating medical institutions across China.

Description

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:

    1. Medical history (History of Present Illness): Positive test result for a respiratory syndrome-related pathogen.
    2. Laboratory testing: Positive test result for a respiratory syndrome-related pathogen.

    3. Medication: Receipt of any of the following antiviral agents:

      Nirmatrelvir/Ritonavir Leritrelvir Xiannuotewei/Ritonavir Molnupiravir Azvudine Deuremidevir

    4. Diagnosis: Diagnosis containing the term "respiratory tract infection."

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Respiratory syndrome cohort
Patients entering fever clinics, emergency departments, outpatient clinics, or inpatient wards who meet the respiratory syndrome screening and diagnostic criteria.
Diagnostic test: Tiered pathogen testing and multi-omics analysis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection rate and pathogen spectrum of respiratory syndrome pathogens among enrolled participants
Time Frame: 3 years
3 years
Immune response and antibody levels after respiratory syndrome-related infection or vaccination
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

July 3, 2026

First Submitted That Met QC Criteria

July 3, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 3, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2025-1002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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