Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System

NCT01775397

Clostridium Difficile

TERMINATED PHASE4

Fidaxomicin to Prevent Clostridium Difficile Colonization

NCT01552668

Clostridium Difficile Infection

WITHDRAWN PHASE4

A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population

NCT02254967

Clostridium Difficile

COMPLETED PHASE4

Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)

NCT04070352

Clostridium Difficile Infection (CDI)

WITHDRAWN

A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections

NCT02692651

Clostridium Difficile Infection (CDI)

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clostridium Difficile Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fidaxomicin treatment

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

Environmental sampling

Intervention Type OTHER

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

Skin swab sampling

Intervention Type OTHER

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

Fecal sampling

Intervention Type OTHER

Collection of fecal samples for C. difficile spores

Metronidazole or vancomycin treatment

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

Environmental sampling

Intervention Type OTHER

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

Skin swab sampling

Intervention Type OTHER

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

Fecal sampling

Intervention Type OTHER

Collection of fecal samples for C. difficile spores

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Environmental sampling

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

Intervention Type OTHER

Skin swab sampling

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

Intervention Type OTHER

Fecal sampling

Collection of fecal samples for C. difficile spores

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No