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临床试验/NCT06190548
NCT06190548已完成不适用

Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection: a Single-centre Cohort Study With Multiplex Analyses in China

West China Hospital1 个研究点 分布在 1 个国家目标入组 556 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
556
试验地点
1
主要终点
30-day mortality

研究概览

简要总结

The goal of this observational study is to learn about the risk factors of mortality for CRKP infected patients, and to compare the clinical outcomes between hvCRKP infection and cCRKP infection. The main question it aims to answer is • Whether hypervirulence would add value to cCRKP infection and cause worse outcomes? Participants data will be collected through medical records.

详细描述

We conducted an observational cohort study comprising three-year (2019-2022) data in a Chinese university hospital. We performed genome sequencing for CRKP strains, compared adult patients infected by hvCRKP with those by non-hypervirulent "classical" CRKP (cCRKP), and used propensity score matching (PSM) for imbalanced baseline characteristics. We defined 30-day all-cause and attributed mortalities and 30-day ranking outcomes (death, no response/progress, remission) as primary outcomes and post-infection stay and survival as secondary outcomes. We constructed mortality-predicting models and performed subgroup analyses for CRKP of the dominant sequence or capsular type or with varied virulence profiles and for patients with bloodstream or lower respiratory tract infections.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥18-year-old) with CRKP infections were included.

排除标准

  • younger than 18 years old; clinical samples were identified to contain CRKP but were sentenced to be colonization

结局指标

主要结局

30-day mortality

时间窗: 30 days

The mortality of patients 30-days after CRKP infection

The number of participants with status

时间窗: 30 days

The status of patients 30 days after CRKP infection, including death, no response or progress, and remission.

次要结局

  • length of stay (LOS) in the hospital(30 days)
  • post-infection survival(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ya Hu

Dr.

West China Hospital

研究点 (1)

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