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NCT Number: NCT04535661

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

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 .

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Key information

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection

Age range

29 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Guoping Lu, MD

CONTACT

[email protected]

18017590817

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. mortality

    Time frame: within 28 days after they discharged from PICU

    The death rate of children in 28 days after their discharged from PICU

Secondary outcomes

  1. length of stay in PICU

    Time frame: within 28 days after they discharged from PICU

    Time from PICU admission to discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Gangfeng Yan

CONTACT

[email protected]

+8615900603082

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2020
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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