Clinical trial NCT02461901: Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Difficile Infection
Keywords: clostridium difficile
environment
contamination
fidaxomicin
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Europe Ltd.
name: The Leeds Teaching Hospitals NHS Trust
name: St George's Healthcare NHS Trust
First posted: 2015-06-03
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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)

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.

Eligibility 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

Primary outcomes:
measure: The presence of environmental contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole.
timeFrame: Up to 28 days after treatment
measure: The presence of skin contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole.
timeFrame: Up to 28 days after treatment
Secondary outcomes:
measure: C.difficile spore counts in the faeces of CDI patients before, during and after treatment with fidaxomicin, vancomycin or metronidazole.
timeFrame: Up to 28 days after treatment
measure: Total C. difficile spore counts from skin swab samples during and following treatment with fidaxomicin, vancomycin or metronidazole.
timeFrame: Up to 28 days after treatment
Other outcomes:
Locations:
city: Tooting
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
state: London
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
state: West Yorkshire
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: West Yorkshire
Study officials:
affiliation: Leeds Teaching Hospitals NHS Trust
name: Mark H Wilcox
role: STUDY_CHAIR
affiliation: St George's Healthcare NHS Trust
name: Tim Planche
role: PRINCIPAL_INVESTIGATOR
affiliation: Bradford Teaching Hospitals NHS Foundation Trust
name: Philip Stanley
role: PRINCIPAL_INVESTIGATOR
References: