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

NCT ID: NCT04535661

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

536 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2026-12-31

Brief Summary

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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 .

Detailed Description

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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.

Conditions

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Carbapenem-Resistant Enterobacteriaceae Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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non CRE

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

No interventions assigned to this group

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.

No interventions assigned to this group

CRE infection

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

29 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gangfeng Yan

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fundan University

Locations

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Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Gangfeng Yan

Role: CONTACT

+8615900603082

Facility Contacts

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Guoping Lu, MD

Role: primary

18017590817

Other Identifiers

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fdpicu-05

Identifier Type: -

Identifier Source: org_study_id

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