Does Using Fidaxomicin to Treat Clostridium Difficile Infection (CDI) Reduce the Recovery of C. Difficile From Patients' Faeces, Skin and Their Immediate Environment, Compared to Treatment With Vancomycin or Metronidazole?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 3
- 主要终点
- The presence of skin contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole.
研究概览
简要总结
This study evaluates whether patients with Clostridium difficile infection (CDI) who are treated with fidaxomicin have less contamination of their skin and surrounding environment with spores of C. difficile than patients treated with other drugs (metronidazole or vancomycin)
详细描述
Fidaxomicin is a newly licensed drug for the treatment of CDI. Patients treated with fidaxomicin have a significantly lower C. difficile spore count in their faeces than patients who receive alternative drugs (metronidazole or vancomycin). In vitro evidence has shown that the drug persists in the gut for several weeks after treatment has finished and also prevents the outgrowth of spores. These findings suggest that fidaxomicin therapy could be associated with less contamination of CDI patient's skin and their surrounding environment than metronidazole or vancomycin therapy.
This prospective, case control study aims to investigate this hypothesis by measuring C. difficile spore counts in patient's stool samples, on their skin and in the surrounding environment. Results for patients receiving fidaxomicin will be compared with those on either metronidazole or vancomycin.
If fidaxomicin therapy does reduce contamination levels, it might be a useful adjunct to existing measures used to control CDI in healthcare settings, particularly in outbreak situations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Diagnosis of CDI (see above)
- •Prescribed fidaxomicin, vancomycin or metronidazole by attending physician
排除标准
- •Patients whose clinical care team indicates it would be inappropriate to include him/her in the study (e.g. due to terminal illness)
- •In a patient receiving metronidazole or vancomycin, receipt of fidaxomicin within the previous 3 months
- •patients unable to give informed consent for whom no consultee is available to give approval
- •non-English speakers
结局指标
主要结局
The presence of skin contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole.
时间窗: Up to 28 days after treatment
The presence of environmental contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole.
时间窗: Up to 28 days after treatment
次要结局
- C.difficile spore counts in the faeces of CDI patients before, during and after treatment with fidaxomicin, vancomycin or metronidazole.(Up to 28 days after treatment)
- Total C. difficile spore counts from skin swab samples during and following treatment with fidaxomicin, vancomycin or metronidazole.(Up to 28 days after treatment)
研究者
Professor Mark Wilcox
Professor of Medical Microbiology
University of Leeds