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Antibiotic

Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)

Phase 4
Waitlist Available
Led By Mindy Sampson, DO
Research Sponsored by University of South Florida
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 90 days
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is testing whether taking oral vancomycin can prevent Clostridium difficile infections from coming back. The study focuses on patients who have had multiple episodes of this infection. Vancomycin is an antibiotic that kills the bacteria causing these infections. Oral vancomycin has been used for the treatment and prevention of Clostridium difficile infections, showing effectiveness in reducing recurrence rates.

Eligible Conditions
  • Clostridium Difficile (C. diff) Infection
  • Clostridium Difficile Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrence Rate
Secondary study objectives
Risk factors associated clostridium difficile infection recurrences

Side effects data

From 2021 Phase 4 trial • 15 Patients • NCT03388268
25%
Abdominal pain
13%
Syncope, altered mental status
13%
Volume overload
13%
Hypoxemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Oral Vancomycin

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
Experimental Treatment
Placebo Group
Group I: Study drugExperimental Treatment1 Intervention
Oral vancomycin 125mg twice a day prescribed for the duration of antibiotics
Group II: PlaceboPlacebo Group1 Intervention
Matched placebo twice a day prescribed for the duration of antibiotics
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Vancomycin
2017
Completed Phase 4
~220

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor
427 Previous Clinical Trials
192,605 Total Patients Enrolled
Mindy Sampson, DOPrincipal InvestigatorUniversity of South Florida
~4 spots leftby Dec 2025
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