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Chinese PICU Collaborative Network on Pathogens and Drug Resistance of Severe Infections

Sponsor
Guoping Lu (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04923828
Collaborator
Shanghai Children's Hospital (Other), Shanghai Children's Medical Center (Other), Ningbo Women & Children's Hospital (Other), Anhui Provincial Children's Hospital (Other), Xian Children's Hospital (Other), The Children's Hospital of Zhejiang University School of Medicine (Other), Qilu Children's Hospital of Shandong University (Other)
2,000
Enrollment
1
Location
49
Anticipated Duration (Months)
40.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate PICUs in major cities in China by establishing a high-quality standardized clinical database of PICU inpatients Incidence, fatality rate, pathogen distribution, anti-infective treatment of community-acquired/nosocomial infections in inpatients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All patients admitted to the PICU during January 1, 2016 to December 31 2025 were included in the study, and all patients were followed up until death or PICU withdrawal. To establish the standardized Access database collected patients' general information, infection, PICU treatment, catheter, and short-term Prognosis and other clinical data.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Children's Hospital of Fudan University
    Anticipated Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Pathogenic spectrum of PICU severe infection [2016-2025]

      the 10 years of pathogenic spectrum of PICU severe infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • PICU patients with severe infection
    Exclusion Criteria:
    • Non-infected patient

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Fudan University Shanghai Shanghai China

    Sponsors and Collaborators

    • Guoping Lu
    • Shanghai Children's Hospital
    • Shanghai Children's Medical Center
    • Ningbo Women & Children's Hospital
    • Anhui Provincial Children's Hospital
    • Xian Children's Hospital
    • The Children's Hospital of Zhejiang University School of Medicine
    • Qilu Children's Hospital of Shandong University

    Investigators

    • Principal Investigator: Guoping Lu, Doctor, Children's Hospital of Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guoping Lu, Chief of PICU, Children's Hospital of Fudan University
    ClinicalTrials.gov Identifier:
    NCT04923828
    Other Study ID Numbers:
    • fdpicu-21
    First Posted:
    Jun 11, 2021
    Last Update Posted:
    Jun 14, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guoping Lu, Chief of PICU, Children's Hospital of Fudan University
    PICU
    pathogen
    severs infection
    drug resistance
    Additional relevant MeSH terms:
    Infections

    Study Results

    No Results Posted as of Jun 14, 2022