Clostridium Difficile Virulence Mechanism Study by Collecting Stool Samples From Clostridium Difficile Infection Patients (CDVM Study)
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
- 否
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
Sunny Wong
Principal Investigator, Clinical Assistant Professor
Chinese University of Hong Kong
