Fidaxomicin to Prevent Clostridium Difficile Colonization

This study has been withdrawn prior to enrollment.
(Study not performed)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01552668
First received: March 8, 2012
Last updated: May 27, 2014
Last verified: May 2014
  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


Enrollment: 0
Study Start Date: September 2012
Study Completion Date: December 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552668

Locations
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
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: May 27, 2014
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:
Infection
Communicable Diseases

ClinicalTrials.gov processed this record on September 18, 2014