Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

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?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02461901

Enrollment

203

Registered

2015-06-03

Start date

2015-01-31

Completion date

2017-12-31

Last updated

2021-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile Infection

Keywords

clostridium difficile, environment, contamination, fidaxomicin

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.

Interventions

OTHEREnvironmental sampling

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

OTHERSkin swab sampling

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

OTHERFecal sampling

Collection of fecal samples for C. difficile spores

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026