Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?
- Conditions
- Clostridium Difficile Infection
- Interventions
- Other: Environmental samplingOther: Skin swab samplingOther: Fecal sampling
- Registration Number
- NCT02461901
- Lead Sponsor
- Professor Mark Wilcox
- Brief Summary
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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 203
- Diagnosis of CDI (see above)
- Prescribed fidaxomicin, vancomycin or metronidazole by attending physician
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fidaxomicin treatment Fecal sampling Patients being treat with fidaxomicin (on the decision of their treating physician) Fidaxomicin treatment Environmental sampling Patients being treat with fidaxomicin (on the decision of their treating physician) Fidaxomicin treatment Skin swab sampling Patients being treat with fidaxomicin (on the decision of their treating physician) Metronidazole or vancomycin treatment Environmental sampling Patients being treated with metronidazole or vancomycin (on the decision of their treating physician) Metronidazole or vancomycin treatment Skin swab sampling Patients being treated with metronidazole or vancomycin (on the decision of their treating physician) Metronidazole or vancomycin treatment Fecal sampling Patients being treated with metronidazole or vancomycin (on the decision of their treating physician)
- Primary Outcome Measures
Name Time Method The presence of skin contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole. Up to 28 days after treatment The presence of environmental contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole. Up to 28 days after treatment
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (3)
Bradford Teaching Hospitals NHS Foundation Trust
🇬🇧Bradford, West Yorkshire, United Kingdom
St George's University Hospitals NHS Foundation Trust
🇬🇧Tooting, London, United Kingdom
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, West Yorkshire, United Kingdom