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

A Retrospective Single Center Study of the Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in PICU Hospitalized Children

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04535661

Enrollment

536

Registered

2020-09-02

Start date

2021-03-01

Completion date

2026-12-31

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection

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 .

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、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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

29 Days to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
mortality	within 28 days after they discharged from PICU	The death rate of children in 28 days after their discharged from PICU

Secondary

Measure	Time frame	Description
length of stay in PICU	within 28 days after they discharged from PICU	Time from PICU admission to discharge

Countries

China

Contacts

CONTACTGangfeng Yan

jinyi036@126.com+8615900603082

PRINCIPAL_INVESTIGATORGangfeng Yan

Children's Hospital of Fundan University

Outcome results