Fidaxomicin to Prevent Clostridium Difficile Colonization

Phase 4

Withdrawn

• Conditions: Clostridium Difficile Infection
• Interventions: Drug: Placebo; Drug: Fidaxomicin

• Registration Number: NCT01552668
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-13
• Study Start: 2012-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-27
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Fidaxomicin	Fidaxomicin	Receive 200 mg of fidaxomicin twice daily

Primary Outcome Measures

Name	Time	Method
Clostridium difficile	At discharge from hospital (average of 7 days after enrollment in study)	Clostridium difficile isolated from patient stool specimen

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 St. Louis, Missouri, United States