vancomycin for 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after treatment for reporting.

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 more

Awards & 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.

Do I qualify?Apply below to find out