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NCT04535661 Clinical Trial

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

Carbapenem-Resistant Enterobacteriaceae Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04535661
Other study ID # fdpicu-05
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date December 31, 2024

Study information
Verified date February 2024
Source Children's Hospital of Fudan University
Contact Gangfeng Yan
Phone +8615900603082
Email jinyi036@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 536
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 29 Days to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
China Children's Hospital of Fudan University Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary mortality The death rate of children in 28 days after their discharged from PICU within 28 days after they discharged from PICU
Secondary length of stay in PICU Time from PICU admission to discharge within 28 days after they discharged from PICU
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