Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

September 8, 2021 updated by: Professor Mark Wilcox

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?

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

203

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • London
      • Tooting, London, United Kingdom, SW19 0QT
        • St George's University Hospitals NHS Foundation Trust
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Bradford Teaching Hospitals NHS Foundation Trust
      • Leeds, West Yorkshire, United Kingdom, LS1 3EX
        • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Clostridium difficile infection.

CDI is defined as the presence of both:

  • a positive C. difficile toxin assay result on a fecal sample, and
  • diarrhea (Bristol stool type 5-7) >/= 3 times in any 24 hour period in the last 7 days

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The presence of environmental contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole.
Time Frame: Up to 28 days after treatment
Up to 28 days after treatment
The presence of skin contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole.
Time Frame: Up to 28 days after treatment
Up to 28 days after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
C.difficile spore counts in the faeces of CDI patients before, during and after treatment with fidaxomicin, vancomycin or metronidazole.
Time Frame: Up to 28 days after treatment
Up to 28 days after treatment
Total C. difficile spore counts from skin swab samples during and following treatment with fidaxomicin, vancomycin or metronidazole.
Time Frame: Up to 28 days after treatment
Up to 28 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Professor Mark Wilcox

Collaborators

The Leeds Teaching Hospitals NHS Trust
Astellas Pharma Europe Ltd.
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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/NW/1398

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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