Skip to main content
OpenTrials
Completed

NCT Number: NCT02461901

Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

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)

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St George's University Hospitals NHS Foundation Trust, Tooting, London, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Environmental sampling

Other

Sampling of five sites in the patient's immediate environment for C. difficile spores

Skin swab sampling

Other

Collection of swabs from three sites on the skin for C. difficile spores

Fecal sampling

Other

Collection of fecal samples for C. difficile spores

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Professor Mark Wilcox

Other

Collaborators

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

Registry information

Official study 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?

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 3, 2015
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.