A Retrospective Single Center Study of the Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in PICU Hospitalized Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 536
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 29 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019.
排除标准
- •discharge within 48 hours
- •patients had a positive culture for CRE before admission
- •incomplete clinical and demographic data
研究组 & 干预措施
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.
结局指标
主要结局
mortality
时间窗: within 28 days after they discharged from PICU
The death rate of children in 28 days after their discharged from PICU
次要结局
- length of stay in PICU(within 28 days after they discharged from PICU)