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Идёт набор NCT07694648

Clinical Multimodal Surveillance of Respiratory Syndrome Pathogens

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Tiered pathogen testing and multi-omics analysis.
Кому может быть актуально
Состояния в реестре: Respiratory Tract Infections (RTI), Respiratory Syndrome, Acute, Severe, Acute Respiratory Infections (ARIs). Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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."

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 31 центр
  • Beijing You'an Hospital, Capital Medical University — Пекин
  • The Fifth Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
  • 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 — Харбин
  • Jiamusi Central Hospital — Jiamusi
  • Shangqiu Municipal Hospital — Shangqiu
  • The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
  • … и ещё 23 центра

Идентификаторы

NCT: NCT07694648 · KY2025-1002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗