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Clinical Multimodal Surveillance of Respiratory Syndrome Pathogens

3 juli 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

2398

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.
Diagnostiskt 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.

Vad mäter studien?

Primära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Huashan Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2025

Primärt slutförande (Beräknad)

31 augusti 2028

Avslutad studie (Beräknad)

30 september 2028

Studieregistreringsdatum

Först inskickad

3 juli 2026

Först inskickad som uppfyllde QC-kriterierna

3 juli 2026

Första postat (Faktisk)

10 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KY2025-1002

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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