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Recruiting NCT07694648

Clinical Multimodal Surveillance of Respiratory Syndrome Pathogens

— Observational Respiratory Tract Infections (RTI) Respiratory Syndrome, Acute, Severe Acute Respiratory Infections (ARIs)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tiered pathogen testing and multi-omics analysis.
Who it may be relevant to
Registry conditions: Respiratory Tract Infections (RTI), Respiratory Syndrome, Acute, Severe, Acute Respiratory Infections (ARIs). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Multimodal Early Warning Surveillance of Respiratory Syndrome Pathogens and Construction and Application of Prevention and Control Measures

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Detection rate and pathogen spectrum of respiratory syndrome pathogens among enrolled participants [Time frame: 3 years]
  • Immune response and antibody levels after respiratory syndrome-related infection or vaccination [Time frame: 3 years]

Eligibility criteria

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 31 centers
  • Beijing You'an Hospital, Capital Medical University — Beijing
  • The Fifth Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai
  • The 980th Hospital of the People's Liberation Army Joint Logistics Support Force — Shijiazhuang
  • Heilongjiang Provincial Hospital — Harbin
  • Jiamusi Central Hospital — Jiamusi
  • Shangqiu Municipal Hospital — Shangqiu
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou
  • … and 23 more centers

Identifiers

NCT: NCT07694648 · KY2025-1002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗