Status:
COMPLETED
Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Medical College of Wisconsin
Agency for Healthcare Research and Quality (AHRQ)
Conditions:
Recurrent Clostridium Difficile Infection
Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 la...
Detailed Description
Many patients who have a CDI experience recurrent or relapsing symptoms. The investigators are studying whether vancomycin in low doses will help prevent further CDI episodes and how this therapy impa...
Eligibility Criteria
Inclusion
- Willing to provide informed consent.
- Willing to comply with all study procedures and be available for the duration of the study.
- Documented diagnosis of at least one CDI within the last 180 days with treatment completed.
- Currently receiving systemic antibiotics for a non-CDI condition with anticipated duration of no more than 2 weeks.
- Females of childbearing potential must have a negative pregnancy test prior to randomization and agree to use adequate contraception prior to randomization, for the duration of the study, and for 4 weeks following study completion.
- Have received no more than 72 hours of non-CDI antibiotics.
Exclusion
- History of hypersensitivity or allergy to oral vancomycin.
- Current use of oral vancomycin
- Patients on concurrent treatment with metronidazole or tetracycline monotherapy for any indication
- Patients diagnosed with inflammatory bowel disorder (Crohn's disease), or bacterial gastrointestinal infection cause by agents other than C. difficile (e.g. Salmonella sp.), toxic megacolon and/or known small bowel ileus.
- Dysphagia (inability to swallow capsules) or unwilling to swallow capsules.
- Major gastrointestinal surgery within 3 months of enrollment (does not include appendectomy or cholecystectomy).
- Any history of total colectomy or bariatric surgery.
- Unable or unwilling to fulfill study requirements.
- Expected life expectancy \< 6 months.
- Patients enrolled in another clinical trial with investigational drugs within 30 days prior to randomization.
- Women who are pregnant or breast-feeding.
- Any patient deemed not suitable for study participation at the discretion of the study investigator.
- Diarrhea (3 or more loose stools in a 24 hour period) at enrollment.
Key Trial Info
Start Date :
May 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2023
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT03462459
Start Date
May 21 2018
End Date
July 6 2023
Last Update
May 25 2025
Active Locations (2)
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1
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705
2
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226