Fidaxomicin to Prevent Clostridium Difficile Colonization

The Washington University

Status and phase

Withdrawn

Phase 4

Conditions

Clostridium Difficile Infection

Treatments

Drug: Placebo

Drug: Fidaxomicin

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT01552668

201109037

1U54CK000162 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)