跳至主要内容
临床试验/NCT03654872
NCT03654872Unknown不适用

Clostridium Difficile Virulence Mechanism Study by Collecting Stool Samples From Clostridium Difficile Infection Patients (CDVM Study)

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 227 人开始时间: 2018年6月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
227
试验地点
1
主要终点
Isolate Clostridium difficile from patients' stool for ribotyping to identify which ribotype was the Clostridium difficile from the patient.

研究概览

简要总结

This study is an observational study to collect stool samples from patients with Clostridium difficile infection (CDI) to investigate the virulence mechanisms of C. difficile ribotypes in Hong Kong, mainly ribotype 002. No intervention is involved.

详细描述

This is an observational study to collect stool samples from patients with Clostridium difficile infection (CDI), aims to (1) to investigate the virulence mechanisms of C. difficile ribotype 002, by analysing its growth, cytotoxicity, and metabolite production in vitro and in vivo. The investigators also aim (2) to compare these virulence mechanisms with other common ribotypes in Asia, and (3) to correlate these with important clinical outcomes. The results of this study will have a major significance to the medical and scientific community. The results of this study will have a major significance to the medical and scientific community. The mechanistic data will point to important molecular pathways that can be targeted for novel therapies; whereas the phenotypic data will inform the investigators of its virulence and therefore will be useful for disease surveillance and public health interventions. The identified toxin(s) and metabolite(s) may be useful as prognostic biomarkers to stratify patients with different outcomes, as patients with a worse outcome may require more aggressive therapy. Given the prevalence and severity of this ribotype, the results will be useful for gastroenterologists, microbiologists, infectious diseases physicians and public health specialists in the Asia Pacific region.

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

入选标准

  • Patients with a confirmed diagnosis of CDI, as documented by diarrheal symptoms and positive stool test result for C. difficile toxin or toxigenic C. difficile, or colonoscopic findings of pseudomembranous colitis (PMC).
  • Patients aged over or equal to 18 years old.
  • Patients able and willing to provide informed consent.

排除标准

  • Patients with concomitant infection by other microbes such as Salmonella, Campylobacter, Vibrio, Shigella, and Escherichia coli.
  • Patients under 18 years old.
  • Patients who cannot give consent.

结局指标

主要结局

Isolate Clostridium difficile from patients' stool for ribotyping to identify which ribotype was the Clostridium difficile from the patient.

时间窗: 1 year

Clostridium difficile will be isolated from stool sample of the patients and will be used for ribotyping. Ribotyping will be done to the Clostridium difficile strain isolated to classify them into different ribotypes. This is to measure the number of patients with a particular ribotype. Virulence mechanism will also be evaluated through experiments with isolated bacteria on growth curve, toxin production, sporulation, germination and adhesion.

次要结局

未报告次要终点

研究者

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

Sunny Wong

Principal Investigator, Clinical Assistant Professor

Chinese University of Hong Kong

研究点 (1)

Loading locations...

相似试验