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Clinical Multimodal Surveillance of Respiratory Syndrome Pathogens

3. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Antatt)

2398

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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.

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Huashan Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2025

Primær fullføring (Antatt)

31. august 2028

Studiet fullført (Antatt)

30. september 2028

Datoer for studieregistrering

Først innsendt

3. juli 2026

Først innsendt som oppfylte QC-kriteriene

3. juli 2026

Først lagt ut (Faktiske)

10. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KY2025-1002

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere