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Fidaxomicin to Prevent Clostridium Difficile Colonization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01552668
Recruitment Status : Withdrawn (Study not performed)
First Posted : March 13, 2012
Last Update Posted : May 28, 2014
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Washington University School of Medicine

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

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: Fidaxomicin Drug: Placebo Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : September 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Fidaxomicin

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Clostridium difficile [ Time Frame: At discharge from hospital (average of 7 days after enrollment in study) ]
    Clostridium difficile isolated from patient stool specimen


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552668


Locations
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United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Centers for Disease Control and Prevention
More Information
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Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01552668    
Other Study ID Numbers: 201109037
1U54CK000162 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014
Keywords provided by Washington University School of Medicine:
Clostridium difficile infection
fidaxomicin
Additional relevant MeSH terms:
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Infections
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
 Bacterial Infections and Mycoses
Fidaxomicin
Anti-Bacterial Agents
Anti-Infective Agents