Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

Clostridium Difficile Infection Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461901
• Other study ID #: 14/NW/1398
• Status: Completed
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2021
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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 information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: December 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Enterocolitis, Pseudomembranous
• Infection

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Bradford Teaching Hospitals NHS Foundation Trust	Bradford	West Yorkshire
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds	West Yorkshire
United Kingdom	St George's University Hospitals NHS Foundation Trust	Tooting	London

Sponsors (4)

Lead Sponsor	Collaborator
Professor Mark Wilcox	Astellas Pharma Europe Ltd., St George's Healthcare NHS Trust, The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of environmental contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole.		Up to 28 days after treatment
Primary	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	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
Secondary	Total C. difficile spore counts from skin swab samples during and following treatment with fidaxomicin, vancomycin or metronidazole.		Up to 28 days after treatment