Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

Condition(s) targeted: Clostridium Difficile Infection

Intervention: Environmental sampling (Other); Skin swab sampling (Other); Fecal sampling (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Professor Mark Wilcox

Official(s) and/or principal investigator(s):
Mark H Wilcox, Study Chair, Affiliation: Leeds Teaching Hospitals NHS Trust
Tim Planche, Principal Investigator, Affiliation: St George's Healthcare NHS Trust

Overall contact:
Damian PC Mawer, Phone: +44113 3928663, Email: damian.mawer@nhs.net

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)

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 design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome:

The presence of environmental contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole.

The presence of skin contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole.

Secondary outcome:

C.difficile spore counts in the faeces of CDI patients before, during and after treatment with fidaxomicin, vancomycin or metronidazole.

Total C. difficile spore counts from skin swab samples during and following treatment with fidaxomicin, vancomycin or metronidazole.

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Damian PC Mawer, Phone: +44113 3928663, Email: damian.mawer@nhs.net

St George's University Hospitals NHS Foundation Trust, Tooting, London SW19 0QT, United Kingdom; Active, not recruiting

Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire LS1 3EX, United Kingdom; Recruiting
Damian P Mawer, MB ChB, Phone: +441133928663, Email: damian.mawer@nhs.net
Claire L Brown, MA, Phone: +441139328663, Email: claire.brown34@nhs.net

Starting date: January 2015
Last updated: June 3, 2015