NCT07221708

Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin

Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin in Patients Treated With Systemic Antibiotic Therapy in a Community Hospital

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 65 Years – 100 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the ability of oral vancomycin in preventing Clostridioides difficile infection (CDI) in patients that are simultaneously receiving antibiotics. Participants in this study will be placed randomly into two groups. The oral vancomycin treatment group will receive oral vancomycin two times per day simultaneously with an antibiotic plus two additional days. The no oral vancomycin control group will receive the current standard of care, which is an antibiotic and no oral vancomycin. Participation in this study will last approximately 3 months.

Detailed description

This research study is being conducted to evaluate the feasibility of prescribing oral vancomycin in preventing CDI in patients who are receiving concomitant systemic antibiotics. There are two groups: one group will receive oral vancomycin 125 mg twice daily for the duration of systemic antibiotic use plus two additional days; the other group will receive the current standard of care which is no oral vancomycin. The investigators aim to collect data from 100 patients in each group for a total of 200 patients. Eligible participants will be randomized in a 1:1 ratio to receive either oral vancomycin or no oral vancomycin. A computer-generated randomization sequence has been created using block randomization with variable block sizes (4, 6, 8) to maintain group balance and reduce predictability.

Conditions

• Clostridioides Difficile
• Vancomycin Resistance Enterococcus Faecium

Interventions

Type	Name	Description
DRUG	Vancomycin (POC)	A dosage of oral vancomycin 125 mg will be given twice daily for the duration of the concomitant antibiotic plus two additional days

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-10-28
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study