NCT04241744

Prospective Trial of Oral Vancomycin Therapy vs. Placebo for Prevention of CDI

Prospective, Randomized, Double-Blind, Trial of Oral Vancomycin Therapy Compared to Placebo As Primary Prevention for C. Difficile-associated Infection (CDI)

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Creighton University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine in patients receiving intravenous (IV) antibiotic(s), if giving oral vancomycin therapy will prevent C. difficile-associated infection (commonly called CDI). Oral vancomycin is an antibiotic that is commonly used to treat CDI. The investigators want to study if using this drug can prevent the development of CDI while you are in the hospital receiving IV antibiotics. The key risk factors for developing CDI are age and IV antibiotic therapy. CDI is an infection in your colon caused by an organism called Clostridium difficile (or C. diff for short) that causes diarrhea. Up to 12% of hospital-acquired infections have been reported to be CDI. It can lead to longer hospital stays and more costs associated with the hospital stay.

Conditions

• CDI

Interventions

Type	Name	Description
DRUG	Vancomycin 125 MG po BID	prevention to develop CDI during hospitalization

Timeline

• Start date: 2019-10-29
• Primary completion: 2020-01-13
• Completion: 2020-01-13
• First posted: 2020-01-27
• Last updated: 2020-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study