Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

Professor Mark Wilcox

Status: Completed

Conditions: Clostridium Difficile Infection

Treatments: Other: Environmental sampling; Other: Fecal sampling; Other: Skin swab sampling

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02461901

14/NW/1398

Details and patient eligibility

About

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)

Full 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.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

203 participants in 2 patient groups

Fidaxomicin treatment

Description:

Patients being treat with fidaxomicin (on the decision of their treating physician)

Treatment:

Other: Skin swab sampling

Other: Fecal sampling

Other: Environmental sampling

Metronidazole or vancomycin treatment

Description:

Patients being treated with metronidazole or vancomycin (on the decision of their treating physician)

Treatment:

Other: Skin swab sampling

Other: Fecal sampling

Other: Environmental sampling