Fidaxomicin to Prevent Clostridium Difficile Colonization



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:September 2012
End Date:March 2016

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Trial Summary
Trial Overview
Inclusion Criteria

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

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

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.

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)
We found this trial at
1
site
Washington University
1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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mi
from
St. Louis, MO
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