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
1 other identifier
observational
536
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
September 2, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 16, 2026
March 1, 2026
5.8 years
August 26, 2020
March 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
mortality
The death rate of children in 28 days after their discharged from PICU
within 28 days after they discharged from PICU
Secondary Outcomes (1)
length of stay in PICU
within 28 days after they discharged from PICU
Study Arms (3)
non CRE
Children with a negative culture for CRE during their stay in PICU are defined as non CRE.
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.
CRE infection
Children who have a positive culture for CRE during their stay in PICU combined with clinical symptoms are defined as CRE infection.
Eligibility Criteria
All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019
You may qualify if:
- All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019.
You may not qualify if:
- discharge within 48 hours
- patients had a positive culture for CRE before admission
- incomplete clinical and demographic data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Study Officials
- PRINCIPAL INVESTIGATOR
Gangfeng Yan
Children's Hospital of Fundan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2020
First Posted
September 2, 2020
Study Start
March 1, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 16, 2026
Record last verified: 2026-03