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Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

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ClinicalTrials.gov Identifier: NCT02461901
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : September 9, 2021
Sponsor:
Collaborators:
Astellas Pharma Europe Ltd.
The Leeds Teaching Hospitals NHS Trust
St George's Healthcare NHS Trust
Information provided by (Responsible Party):
Professor Mark Wilcox, University of Leeds

Study Description
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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
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
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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 : January 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
Drug Information available for: Fidaxomicin

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Biospecimen Retention:   Samples Without DNA
Isolates of Clostridium difficile

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461901


Locations
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United Kingdom
St George's University Hospitals NHS Foundation Trust
Tooting, London, United Kingdom, SW19 0QT
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, West Yorkshire, United Kingdom, BD9 6RJ
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
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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
More Information
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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: June 3, 2015    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Professor Mark Wilcox, University of Leeds:
clostridium difficile
environment
contamination
fidaxomicin
Additional relevant MeSH terms:
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Infections
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses