Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:23 PM
Study NCT ID:
NCT04535661
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2020-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in Children
Sponsor:
Children's Hospital of Fudan University
Organization:
Study Overview
Official Title:
A Retrospective Single Center Study of the Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in PICU Hospitalized Children
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-CREćCRE 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: