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Clinical Multimodal Surveillance of Respiratory Syndrome Pathogens

3. juli 2026 opdateret af: Jingwen Ai, Huashan Hospital

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

2398

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100069
        • Rekruttering
        • Beijing You'an Hospital, Capital Medical University
        • Kontakt:
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510700
        • Rekruttering
        • The Fifth Affiliated Hospital of Guangzhou Medical University
        • Kontakt:
      • Zhuhai, Guangdong, Kina, 519000
        • Rekruttering
        • The Fifth Affiliated Hospital of Sun Yat-sen University
        • Kontakt:
    • Hebei
      • Shijiazhuang, Hebei, Kina, 050082
        • Rekruttering
        • The 980th Hospital of the People's Liberation Army Joint Logistics Support Force
        • Kontakt:
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150036
        • Rekruttering
        • Heilongjiang Provincial Hospital
        • Kontakt:
      • Jiamusi, Heilongjiang, Kina, 154002
        • Rekruttering
        • Jiamusi Central Hospital
        • Kontakt:
    • Henan
      • Shangqiu, Henan, Kina, 476000
        • Rekruttering
        • Shangqiu Municipal Hospital
        • Kontakt:
      • Zhengzhou, Henan, Kina, 450052
        • Rekruttering
        • The First Affiliated Hospital of Zhengzhou University
        • Kontakt:
    • Hubei
      • Yichang, Hubei, Kina, 443003
        • Rekruttering
        • Yichang Third People's Hospital
        • Kontakt:
          • Zhu Jin
          • Telefonnummer: 18654108@qq.co +86 13308608938
    • Hunan
      • Huaihua, Hunan, Kina, 418000
        • Rekruttering
        • Hunan University of Medicine General Hospital
        • Kontakt:
    • Inner Mongolia
      • Baotou, Inner Mongolia, Kina, 014040
        • Rekruttering
        • The Third Hospital of Baotou (Baotou City Hospital for Infectious Diseases)
        • Kontakt:
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210022
        • Rekruttering
        • Nanjing Hospital of Chinese Medicine
        • Kontakt:
      • Nantong, Jiangsu, Kina, 226006
        • Rekruttering
        • The Third People's Hospital of Nantong (Nantong Hospital of Infectious Diseases)
        • Kontakt:
      • Wuxi, Jiangsu, Kina, 214005
        • Rekruttering
        • Wuxi Fifth People's Hospital
        • Kontakt:
    • Jiangxi
      • Jiujiang, Jiangxi, Kina, 332000
        • Rekruttering
        • Jiujiang No.1 People's Hospital
        • Kontakt:
    • Liaoning
      • Shenyang, Liaoning, Kina, 110006
        • Rekruttering
        • Shenyang Sixth People's Hospital
        • Kontakt:
    • Shaanxi
      • Yan’an, Shaanxi, Kina, 716000
        • Rekruttering
        • Affiliated Hospital of Yan'an University
        • Kontakt:
    • Shandong
      • Zaozhuang, Shandong, Kina, 277100
        • Rekruttering
        • Zaozhuang Municipal Hospital
        • Kontakt:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200233
        • Rekruttering
        • Shanghai Sixth People's Hospital
        • Kontakt:
      • Shanghai, Shanghai Municipality, Kina, 200120
        • Rekruttering
        • Shanghai East Hospital
        • Kontakt:
      • Shanghai, Shanghai Municipality, Kina, 200040
        • Rekruttering
        • Huashan Hospital Fudan University
        • Kontakt:
      • Shanghai, Shanghai Municipality, Kina, 200136
        • Rekruttering
        • Jinyang Community Health Service Center of Pudong New Area, Shanghai
        • Kontakt:
      • Shanghai, Shanghai Municipality, Kina, 201399
        • Rekruttering
        • Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
        • Kontakt:
    • Shanxi
      • Taiyuan, Shanxi, Kina, 030001
        • Rekruttering
        • First Hospital of Shanxi Medical University
        • Kontakt:
      • Taiyuan, Shanxi, Kina, 030013
        • Rekruttering
        • Children's Hospital of Shanxi Province
        • Kontakt:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300162
        • Rekruttering
        • Characteristic Medical Center of Chinese People's Armed Police Force
        • Kontakt:
    • Xinjiang
      • Altay, Xinjiang, Kina, 836500
        • Rekruttering
        • Altay Prefecture People's Hospital, Xinjiang
        • Kontakt:
      • Changji, Xinjiang, Kina, 831100
        • Rekruttering
        • Changji Hui Autonomous Prefecture People's Hospital
        • Kontakt:
      • Ürümqi, Xinjiang, Kina, 830054
        • Rekruttering
        • The First Affiliated Hospital of Xinjiang Medical University
        • Kontakt:
    • Yunnan
      • Hekou, Yunnan, Kina, 661399
        • Rekruttering
        • Hekou Yao Autonomous County People's Hospital
        • Kontakt:
      • Kunming, Yunnan, Kina, 650032
        • Rekruttering
        • The First People's Hospital of Yunnan Province
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with respiratory syndrome treated in fever clinics, emergency departments, outpatient clinics, or inpatient wards of participating medical institutions across China.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Respiratory syndrome cohort
Patients entering fever clinics, emergency departments, outpatient clinics, or inpatient wards who meet the respiratory syndrome screening and diagnostic criteria.
Diagnostisk 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Detection rate and pathogen spectrum of respiratory syndrome pathogens among enrolled participants
Tidsramme: 3 years
3 years
Immune response and antibody levels after respiratory syndrome-related infection or vaccination
Tidsramme: 3 years
3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Huashan Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2025

Primær færdiggørelse (Anslået)

31. august 2028

Studieafslutning (Anslået)

30. september 2028

Datoer for studieregistrering

Først indsendt

3. juli 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY2025-1002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Respiratorisk syndrom, akut, svær

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Saudi Arabia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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