NCT01552668

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
DRUG	Fidaxomicin	Receive 200 mg of fidaxomicin twice daily
DRUG	Placebo	Receive Placebo twice daily

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-03-13
• Last updated: 2014-05-28

Locations

1 site across 1 country: United States