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Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in Children

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04535661
Collaborator
(none)
536
Enrollment
1
Location
21
Anticipated Duration (Months)
25.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Carbapenem-resistant Enterobacteriaceae (CRE) are increasingly identified in children in China. Pediatric intensive care unit (PICU) is the high-risk area. However, data on the epidemiology of CRE in hospitalized children in PICU are limited. The objectives of this study are to characterize the risk factors for colonization or infection with CRE and describe the microbiologic characteristics of pediatric CRE isolates. The investigators will perform a single retrospective study from January 2018 to December 2019 at PICU of Children's Hospital of Fudan University .

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit PICU of Children's Hospital of Fudan University from January 2018 to December 2019. Children who had positive cultures for any Enterobacteriaceae species before their admission will be excluded. Children with a PICU length of day less than 48h will also be excluded. According to their clinical cultures results, they will be divided into non-CRE态CRE colonization and CRE infection. CRE was defined according to the 2015 Centers for Disease Control and Prevention (CDC) definition as an isolate resistant to imipenem, meropenem, or ertapenem. Clinical and demographic data will be collected from the electronic health record.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    536 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Retrospective Single Center Study of the Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in PICU Hospitalized Children
    Actual Study Start Date :
    Mar 1, 2021
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    non CRE

    Children with a negative culture for CRE during their stay in PICU are defined as non CRE.
    CRE colonization

    Children who have a positive culture for CRE during their stay in PICU but lack of clinical symptoms are defined as CRE colonization.
    CRE infection

    Children who have a positive culture for CRE during their stay in PICU combined with clinical symptoms are defined as CRE infection.

    Outcome Measures

    Primary Outcome Measures

    1. mortality [within 28 days after they discharged from PICU]

      The death rate of children in 28 days after their discharged from PICU

    Secondary Outcome Measures

    1. length of stay in PICU [within 28 days after they discharged from PICU]

      Time from PICU admission to discharge

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    29 Days to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019.
    Exclusion Criteria:

    • discharge within 48 hours

    • patients had a positive culture for CRE before admission

    • incomplete clinical and demographic data

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Children's Hospital of Fudan University

    Investigators

    • Principal Investigator: Gangfeng Yan, Children's Hospital of Fundan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital of Fudan University
    ClinicalTrials.gov Identifier:
    NCT04535661
    Other Study ID Numbers:
    • fdpicu-05
    First Posted:
    Sep 2, 2020
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Enterobacteriaceae Infections

    Study Results

    No Results Posted as of Apr 12, 2022