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临床试验/NCT05492539
NCT05492539招募中不适用

Incidence and Risk Factors for Developing Infections in Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae

Hospital Italiano de Buenos Aires1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
CRKP infections in CRKP colonized patients

研究概览

简要总结

The worldwide increase in the rate of infections due to multidrug-resistant bacteria is considered a major public health problem.

Infections caused by carbapenem-resistant Klebsiella pneumoniae (CR-KP) are associated with high morbidity and mortality. Mortality of up to 70% and, in survivors, a readmission rate of up to 72% within 90 days of discharge have been reported.

CR-KP infection is usually preceded by colonization. However, the incidence rate and risk factors for CR-KP infections among carriers is poorly understood.

Multiple studies have focused in risk factors to develop infections among carriers.

In order to identify patients at low risk of CR-KP bloodstream infections, Gianella et at developed a predictive score to stratify patients according to their risk for acquisition of CR-KP infections.

However, further studies are needed to validate these results, particularly in high-risk patients, such as haematological patients, solid organ trasplant recipients and patients admitted in ICU.

Italian Hospital is an acute tertiary care university teaching hospital with more than 45,000 admission-years, in Buenos Aires, Argentina, with a great proportion of haematological and solid organ transplant recipients, and patients with substantial comorbidities and immunosuppression.

With the aim of developing an adequate risk assessment for CR-KP infections among CR-KP carriers, we performed a retrospective cohort analysis, in a tertiary teaching hospital in Buenos Aires, Argentina.

The main purpose of our study is to describe the incidence of CR-KP infections among CRKP colonized patients, to demonstrate the risk factors for acquisition of CR-KP infections and to develop a clinical predictive score that could stratify patients to guide therapeutic decisions in CR-KP carriers, and avoid overuse of broad-spectrum therapy.

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 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (≥18 years) patients with a CR-KP positive rectal swab, hospitalized from 01/2014 to 01/2019

排除标准

  • Unwillingness to participate

结局指标

主要结局

CRKP infections in CRKP colonized patients

时间窗: through study completion, an average of 1 year

the presence of a positive clinical culture of CR-KP, a documented physician diagnosis, and the initiation of targeted antimicrobial therapy.

次要结局

  • 30 day all-cause mortality(through study completion, an average of 1 year)

研究者

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

MARINA VALINOTI

Principal Investigaror

Hospital Italiano de Buenos Aires

研究点 (1)

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