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Clinical Multimodal Surveillance of Respiratory Syndrome Pathogens

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07694648
Enrollment
2398
Registered
2026-07-10
Start date
2025-09-01
Completion date
2028-09-30
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Respiratory syndrome, respiratory pathogens, clinical surveillance, early warning, multiplex PCR, metagenomic next-generation sequencing, multi-omics, nationwide multicenter study

Brief 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 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_TESTTiered 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.

Sponsors

Huashan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Detection rate and pathogen spectrum of respiratory syndrome pathogens among enrolled participants3 years
Immune response and antibody levels after respiratory syndrome-related infection or vaccination3 years

Countries

China

Contacts

CONTACTJingwen Ai, M.D.
jingwenai@fudan.edu.cn+86 17317958269

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026