Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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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?

Conditions
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Clostridium Difficile Infection

Intervention / Treatment
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* Other: Environmental sampling
* Other: Skin swab sampling
* Other: Fecal sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of CDI (see above) Prescribed fidaxomicin, vancomycin or metronidazole by attending physician Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fidaxomicin treatment<br>Patients being treat with fidaxomicin (on the decision of their treating physician) | Other: Environmental sampling<br>* Sampling of five sites in the patient's immediate environment for C. difficile spores<br>Other: Skin swab sampling<br>* Collection of swabs from three sites on the skin for C. difficile spores<br>Other: Fecal sampling<br>* Collection of fecal samples for C. difficile spores<br>|
| Metronidazole or vancomycin treatment<br>Patients being treated with metronidazole or vancomycin (on the decision of their treating physician) | Other: Environmental sampling<br>* Sampling of five sites in the patient's immediate environment for C. difficile spores<br>Other: Skin swab sampling<br>* Collection of swabs from three sites on the skin for C. difficile spores<br>Other: Fecal sampling<br>* Collection of fecal samples for C. difficile spores<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | Up to 28 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clostridium difficile, environment, contamination, fidaxomicin