A Prospective Study to Characterize the Management and Outcome of Clostridium Difficile Infection （CDI) in Asian Pacific Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 主要终点
- Status at the End of CDI Episode
研究概览
简要总结
The aim of this study is to conduct an Asia-Pacific, multi-center, prospective observational study to characterize patients with CDI as well as to understand treatment and management of the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of CDI, as documented by diarrheal symptoms and positive stool test result for CDT or toxigenic C. difficile, or colonoscopic findings of PMC
- •Patients and/or legal guardian willing to provide informed consent and/or informed assent or data release, according to local regulations
排除标准
- •Patients with diarrheal symptoms caused by bacteria other than C. difficile, such as Salmonella, Campylobacter, Vibrio, Shigella, and Escherichia coli.
结局指标
主要结局
Status at the End of CDI Episode
时间窗: From the time of CDI diagnosis to the end of the treatment
The patients were observed from the diagnosis to the end of the treatment and got a telephone follow up call after two month from the end of treatment. The categories of the status indicating below are at the end of the treatment, not at the follow up call. Lost to follow-up means the patient number who were lost during the treatment course.
Patient Demographics
时间窗: At the study at the time of CDI diagnosis enrollment
Medical history is information which was collected at the CDI diagnosis in this study. The items of the Medical history are indicated below. Concomitant diseases at the CDI diagnosis were included in the Medical history.
次要结局
- Clinical Complication(From the time of CDI diagnosis to recovery or recurrence)
- Recurrence or Not After 2 Months Follow-up(From the time of CDI diagnosis to 2 months follow-up)