Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea

Hanyang University Seoul Hospital0 个研究点目标入组 500 人开始时间: 2020年10月1日最近更新: 2020年9月28日

适应症

试验速览

阶段: 不适用
发起方
入组人数: 500
主要终点: incidence of CDI

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Our objective of this study is to derive a real incidence of CDI in tertiary hospitals located through Korean peninsula. In order to get a close value to the truth, the study is planned to co-perform with a national study which was proposed in evaluation process to include more hospitals. Along with the incidence of CDI, clinical characteristics and outcome of CDI will be examined and microbiologic characteristics of C. difficile isolates from CDI patients are studied.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

入排标准

年龄范围: 19 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•aged older than 19 years
•more than 3 times of unformed stools passage per day
•positive results of toxin gene test: GDH (+) + PCR (+), GDH (+) + toxin (+), or PCR (+) + toxin (+)
•agree with informed consent

排除标准

•less than 3 times of unformed stool passage per day
•use of oral metronidazole or vancomycin more than 24 hours before enrollment
•use of laxative before enrollment
•recurrent episode of CDI
•disagree with study protocol

结局指标

主要结局

incidence of CDI

时间窗: through Oct 2020 to Dec 2021

Incidence of CDI among hospitalized adults per 100,000 patient\*days/10,000 patient\*admission in enrolled tertiary hospitals.

次要结局

mortality rate(through Oct 2020 to May 2022)
recurrence rate(through Oct 2020 to May 2022)

研究者

发起方

Hanyang University Seoul Hospital

申办方类型

Other

责任方

Sponsor

相似试验

已完成

不适用

Protocol for Admission Toxigenic C. Difficile SurveillanceClostridium Difficile Infection

NCT04014608NorthShore University HealthSystem148,549

已完成

不适用

Epidemiology of Clostridium difficile infection in JapaClostridium difficile infection (CDI)

JPRN-UMIN000015336ational Institute of Infectious Diseases566

尚未招募

3 期

Fecal Filtrate as a Treatment Option of Multiple Recurrent Clostridioides Difficile InfectionClostridium Difficile InfectionRecurrent Clostridium Difficile Infection

NCT04960306University of Pecs238

已完成

不适用

Evaluation of the Cost of a Nosocomial Infection With Clostridium DifficileCross InfectionClostridium Difficile Infection

NCT03025672Lille Catholic University10,445

招募中

不适用

Changes in Recipients Gut Microbiota After Fecal Microbiota TransplantationClostridioides Difficile Infection Recurrence

NCT05739825Fondazione Policlinico Universitario Agostino Gemelli IRCCS20