NCT02461901

Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

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?

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 203 (actual)
• Sponsor: Professor Mark Wilcox · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
OTHER	Environmental sampling	Sampling of five sites in the patient's immediate environment for C. difficile spores
OTHER	Skin swab sampling	Collection of swabs from three sites on the skin for C. difficile spores
OTHER	Fecal sampling	Collection of fecal samples for C. difficile spores

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-12-31
• Completion: 2017-12-01
• First posted: 2015-06-03
• Last updated: 2021-09-09

Locations

3 sites across 1 country: United Kingdom