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临床试验/NCT07694648
NCT07694648招募中不适用

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

Huashan Hospital31 个研究点 分布在 1 个国家目标入组 2,398 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,398
试验地点
31
主要终点
Immune response and antibody levels after respiratory syndrome-related infection or vaccination

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.
  • 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."

排除标准

  • 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.

结局指标

主要结局

Immune response and antibody levels after respiratory syndrome-related infection or vaccination

时间窗: 3 years

Detection rate and pathogen spectrum of respiratory syndrome pathogens among enrolled participants

时间窗: 3 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jingwen Ai

Doctor

Huashan Hospital

研究点 (31)

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