Screening to Prophylax Against Clostridium Difficile Infection -
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Clostridium Difficile Infection
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 investigato...
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 PCR. 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 PO q6 hours as prophylaxis against C. difficile for the duration of their antibiotic treatment +3 days. Arm 2: Patients receive placebo PO q6 hours for the duration of their antibiotic treatment +3 days.
Tracking Information
- NCT #
- NCT02996487
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Matthew Sims, MD PhD Beaumont Health
Get Well Soon