Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

• Sponsor: Professor Mark Wilcox (Other)
• Overall Status: Completed
• CT.gov ID: NCT02461901
• Collaborator: Astellas Pharma Europe Ltd. (Industry), The Leeds Teaching Hospitals NHS Trust (Other), St George's Healthcare NHS Trust (Other)
• Enrollment: 203
• Locations: 3
• Duration (Months): 35
• Patients Per Site: 67.7
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Clostridium Difficile Infection	Other: Environmental sampling; Other: Skin swab sampling; Other: Fecal sampling

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 203 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• 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?
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Dec 31, 2016
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Fidaxomicin treatment Patients being treat with fidaxomicin (on the decision of their treating physician)	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
Metronidazole or vancomycin treatment Patients being treated with metronidazole or vancomycin (on the decision of their treating physician)	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

Outcome Measures

Primary Outcome Measures

1. The presence of environmental contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole. [Up to 28 days after treatment]

2. 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

1. 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]

2. Total C. difficile spore counts from skin swab samples during and following treatment with fidaxomicin, vancomycin or metronidazole. [Up to 28 days after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St George's University Hospitals NHS Foundation Trust	Tooting	London	United Kingdom	SW19 0QT
2	Bradford Teaching Hospitals NHS Foundation Trust	Bradford	West Yorkshire	United Kingdom	BD9 6RJ
3	Leeds Teaching Hospitals NHS Trust	Leeds	West Yorkshire	United Kingdom	LS1 3EX

Sponsors and Collaborators

• Professor Mark Wilcox
• Astellas Pharma Europe Ltd.
• The Leeds Teaching Hospitals NHS Trust
• St George's Healthcare NHS Trust

Investigators

• Study Chair: Mark H Wilcox, Leeds Teaching Hospitals NHS Trust
• Principal Investigator: Tim Planche, St George's Healthcare NHS Trust
• Principal Investigator: Philip Stanley, Bradford Teaching Hospitals NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Professor Mark Wilcox, Professor of Medical Microbiology, University of Leeds
• ClinicalTrials.gov Identifier: NCT02461901
• Other Study ID Numbers: 14/NW/1398
• First Posted: Jun 3, 2015
• Last Update Posted: Sep 9, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Professor Mark Wilcox, Professor of Medical Microbiology, University of Leeds: clostridium difficile; environment; contamination; fidaxomicin
• Additional relevant MeSH terms: Infections; Clostridium Infections

Study Results

No Results Posted as of Sep 9, 2021