About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Diagnosis: Diagnosis containing the term "respiratory tract infection."
Disqualifiers
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 population
Patients with respiratory syndrome treated in fever clinics, emergency departments, outpatient clinics, or inpatient wards of participating medical institutions across China.
Trial design
Cohort
Prospective
Treatments tested in this trial
Tiered pathogen testing and multi-omics analysis
Diagnostic testParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Detection rate and pathogen spectrum of respiratory syndrome pathogens among enrolled participants
Immune response and antibody levels after respiratory syndrome-related infection or vaccination
Sponsors and contacts
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