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Antibiotic
Screening to Prophylax Against Clostridium Difficile Infection - (StoP CDI Trial)
Phase 4
Waitlist Available
Led By Matthew Sims, MD PhD
Research Sponsored by William Beaumont Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after antibiotics
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial is testing if taking vancomycin by mouth can prevent C. difficile infections in hospitalized patients who need other antibiotics. The study focuses on patients who already have C. difficile bacteria in their system. Vancomycin works by killing or stopping the growth of these bacteria to prevent them from causing an infection. Vancomycin has been used before to prevent these infections and has been effective in reducing their return.
Eligible Conditions
- Clostridium Difficile (C. diff) Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks after treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile.
Secondary study objectives
The Incidence of CDI in Patients Initiated on High Risk Antibiotics Who Are Not Colonized With Toxigenic C. Difficile.
The Outcome of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo.
The Prevalence of Toxigenic C. Difficile Colonization Among the Inpatient Population Treated With High-risk Antibiotics Based on C. Difficile PCR.
+1 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: vancomycinActive Control1 Intervention
Vancomycin 125 mg by mouth every 6 hours
Group II: PlaceboPlacebo Group1 Intervention
Placebo every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin.
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Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
152 Previous Clinical Trials
111,466 Total Patients Enrolled
Matthew Sims, MD PhDPrincipal InvestigatorBeaumont Health
2 Previous Clinical Trials
141 Total Patients Enrolled