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

Recruiting

• Conditions: Carbapenem-Resistant Enterobacteriaceae Infection

• Registration Number: NCT04535661
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-09-02
• Study Start: 2021-03-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 536

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
length of stay in PICU	within 28 days after they discharged from PICU	Time from PICU admission to discharge

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China