NCT02996487

Screening to Prophylax Against Clostridium Difficile Infection -

Screening to Prophylax Against Clostridium Difficile Infection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,294 (actual)
• Sponsor: Corewell Health East · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in patients who are colonized with C. difficile who are admitted to the hospital and need antibiotics for another infection.

Detailed description

Screening to Prophylax against CDI (SToP CDI) is a prospective, single-center, double-blinded, randomized, placebo-controlled study of the effectiveness of vancomycin vs. placebo for preventing CDI in patients colonized with toxigenic C. difficile and receiving high-risk antibiotics. The investigators plan to screen 2500 patients to randomize 200. Consented patients will have a stool sample collected and tested for presence of toxigenic C. difficile by polymerase chain reaction (PCR) test. Patients who test negative will simply be followed for development, severity and outcome of CDI. Patients who test positive (are colonized with C. difficile) will be randomized to one of two arms: Arm 1: Patients receive 125 mg vancomycin by mouth (PO) every 6 hours as prophylaxis against C. difficile for the duration of their antibiotic treatment +3 days. Arm 2: Patients receive placebo by mouth (PO) every 6 hours for the duration of their antibiotic treatment +3 days.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
DRUG	Vancomycin
OTHER	Placebo

Timeline

• Start date: 2016-12-19
• Primary completion: 2023-06-28
• Completion: 2023-06-28
• First posted: 2016-12-19
• Last updated: 2024-08-13
• Results posted: 2024-08-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study