Clostridium Difficile Infection
Conditions
Keywords
Clostridium difficile infection, fidaxomicin
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.
Interventions
DRUGFidaxomicin
Receive 200 mg of fidaxomicin twice daily
DRUGPlacebo
Receive Placebo twice daily
Sponsors
Centers for Disease Control and Prevention
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clostridium difficile | At discharge from hospital (average of 7 days after enrollment in study) | Clostridium difficile isolated from patient stool specimen |
Countries
United States
Outcome results
None listed