NCT02461901

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

June 1, 2015

Last Update Submit

September 8, 2021

Conditions

Clostridium Difficile Infection

Keywords

clostridium difficileenvironmentcontaminationfidaxomicin

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

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

    Up to 28 days after treatment

Study Arms (2)

Fidaxomicin treatment

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

Other: Environmental samplingOther: Skin swab samplingOther: Fecal sampling

Metronidazole or vancomycin treatment

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

Other: Environmental samplingOther: Skin swab samplingOther: Fecal sampling

Interventions

Environmental samplingOTHER

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

Fidaxomicin treatmentMetronidazole or vancomycin treatment
Skin swab samplingOTHER

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

Fidaxomicin treatmentMetronidazole or vancomycin treatment
Fecal samplingOTHER

Collection of fecal samples for C. difficile spores

Fidaxomicin treatmentMetronidazole or vancomycin treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Diagnosis of CDI (see above)
  • Prescribed fidaxomicin, vancomycin or metronidazole by attending physician

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

St George's University Hospitals NHS Foundation Trust

Tooting, London, SW19 0QT, United Kingdom

Location

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Isolates of Clostridium difficile

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Mark H Wilcox

    Leeds Teaching Hospitals NHS Trust

    STUDY CHAIR

  • Tim Planche

    St George's Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

  • Philip Stanley

    Bradford Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medical Microbiology

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 3, 2015

Study Start

January 1, 2015

Primary Completion

December 31, 2016

Study Completion

December 1, 2017

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

GB(3)