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Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection

NCT03462459 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2025-05-25

Study results available
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Summary

This study evaluates the efficacy of prophylaxis with oral vancomycin for preventing recurrent Clostridium difficile Infection (CDI) in patients who have experienced at least one CDI episode in the last 180 days and are receiving antibiotics for a non CDI condition. Participants will be randomized to receive either placebo or oral vancomycin in addition to their prescribed antibiotic therapy.

Conditions

  • Recurrent Clostridium Difficile Infection
  • Clostridium Difficile Infection
  • CDI
  • C.Difficile Diarrhea
  • C. Diff Colitis
  • C.Difficile Colitis

Interventions

DRUG

Vancomycin

Vancomycin capsule, 125 mg

DRUG

Placebo

Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule

Sponsors & Collaborators

  • Medical College of Wisconsin

    collaborator OTHER

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • Henry Ford Hospital

    collaborator OTHER

  • Mayo Clinic

    collaborator OTHER

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Nasia Safdar, MD PhD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2023-07-06
Completion
2023-07-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03462459 on ClinicalTrials.gov