Fidaxomicin to Prevent Clostridium Difficile Colonization

This study is not yet open for participant recruitment.
Verified July 2012 by Washington University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01552668
First received: March 8, 2012
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

The purpose of this research study is to evaluate the effectiveness of an antibiotic called fidaxomicin in preventing C. difficile infection.


Condition Intervention Phase
Clostridium Difficile Infection
Drug: Fidaxomicin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of a Twice Daily, 200 mg Dose of Oral Fidaxomicin Compared to Placebo on Risk of Acquiring C. Difficile and Developing C. Difficile Infection (CDI) in High Risk Patients

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Clostridium difficile [ Time Frame: At discharge from hospital (average of 7 days after enrollment in study) ] [ Designated as safety issue: No ]
    Clostridium difficile isolated from patient stool specimen


Estimated Enrollment: 418
Study Start Date: September 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fidaxomicin
Receive 200 mg of fidaxomicin twice daily
Drug: Fidaxomicin
Receive 200 mg of fidaxomicin twice daily
Other Name: Dificid
Placebo Comparator: Placebo Drug: Placebo
Receive Placebo twice daily

Detailed Description:

A novel approach to prevent C. difficile infection is to use compounds with activity against C. difficile as primary prophylaxis in high risk patients. Chemoprophylaxis theoretically can prevent C. difficile infection by two mechanisms. It may reduce transmission from asymptomatic C. difficile carriers by reducing the number of spores shed in the stool and prevent replication and subsequent toxin production of the organisms in patients at risk for C. difficile infection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years old
  • On broad spectrum antimicrobials
  • Anticipated length of stay of > 48 hours after enrollment
  • A non-ICU inpatient

Exclusion Criteria:

  • Pregnant
  • Expected to die within 7 days
  • Have previously been enrolled in this trial or a trial of an investigational agent to treat CDI, and/or are on monotherapy with an antimicrobial generally considered not to increase the risk of CDI (vanc, macrolides, tetracyclines, trimethoprim/sulfamethoxazole, aminoglycosides, colistin, linezolid, nitrofurantoin, metronidazole)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552668

Locations
United States, Missouri
Washington University in St. Louis Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Kerry Bommarito, MPH    314-454-8221    kbommari@dom.wustl.edu   
Principal Investigator: Erik Dubberke, MD         
Sub-Investigator: Victoria J Fraser, MD         
Sponsors and Collaborators
Washington University School of Medicine
  More Information

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01552668     History of Changes
Other Study ID Numbers: 201109037, 1U54CK000162
Study First Received: March 8, 2012
Last Updated: July 19, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Washington University School of Medicine:
Clostridium difficile infection
fidaxomicin

Additional relevant MeSH terms:
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014