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| Name | Class |
|---|---|
| Astellas Pharma Europe Ltd. | INDUSTRY |
| The Leeds Teaching Hospitals NHS Trust | OTHER |
| St George's Healthcare NHS Trust | OTHER |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fidaxomicin treatment | Patients being treat with fidaxomicin (on the decision of their treating physician) |
| |
| Metronidazole or vancomycin treatment | Patients being treated with metronidazole or vancomycin (on the decision of their treating physician) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Environmental sampling | Other | Sampling of five sites in the patient's immediate environment for C. difficile spores |
|
| Measure | Description | Time Frame |
|---|---|---|
| The presence of environmental contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole. | Up to 28 days after treatment | |
| The presence of skin contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole. | Up to 28 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Clostridium difficile infection.
CDI is defined as the presence of both:
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| Name | Affiliation | Role |
|---|---|---|
| Mark H Wilcox | Leeds Teaching Hospitals NHS Trust | Study Chair |
| Tim Planche | St George's Healthcare NHS Trust | Principal Investigator |
| Philip Stanley | Bradford Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St George's University Hospitals NHS Foundation Trust | Tooting | London | SW19 0QT | United Kingdom | ||
| Bradford Teaching Hospitals NHS Foundation Trust |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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Isolates of Clostridium difficile
| Skin swab sampling | Other | Collection of swabs from three sites on the skin for C. difficile spores |
|
| Fecal sampling | Other | Collection of fecal samples for C. difficile spores |
|
| Up to 28 days after treatment |
| Bradford |
| West Yorkshire |
| BD9 6RJ |
| United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | West Yorkshire | LS1 3EX | United Kingdom |