Fidaxomicin to Prevent Clostridium Difficile Colonization

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)