Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
5 other identifiers
interventional
79
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2018
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2018
CompletedFirst Posted
Study publicly available on registry
March 12, 2018
CompletedStudy Start
First participant enrolled
May 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2023
CompletedResults Posted
Study results publicly available
May 25, 2025
CompletedMay 25, 2025
May 1, 2025
5.1 years
February 28, 2018
November 1, 2024
May 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrent Clostridium Difficile Infection (CDI)
Determine whether CDI recurrence is decreased in patients taking oral vancomycin as prophylactic therapy in addition to standard-of-care antibiotics that patients are taking for non-CDI reasons.
8 weeks
Secondary Outcomes (3)
Gut Microbiome Composition
8 weeks
Vancomycin-resistant Enterococcus (VRE) Colonization in Stool Samples of Patients Receiving Vancomycin vs. Patients Receiving Placebo
8 weeks
Determine Whether Clostridium Difficile Positivity on Any Stool Sample is a Predictor of CDI Recurrence.
8 weeks
Study Arms (2)
Vancomycin
EXPERIMENTAL125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Placebo
PLACEBO COMPARATOR125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- Medical College of Wisconsincollaborator
- Agency for Healthcare Research and Quality (AHRQ)collaborator
- Henry Ford Hospitalcollaborator
- Mayo Cliniccollaborator
Study Sites (2)
University of Wisconsin-Madison
Madison, Wisconsin, 53705, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Keating JA, Xu T, Graham MB, Ramesh M, Khanna S, Dixon J, Kates A, Haight K, Zhao J, Saddler C, Safdar N. Oral Vancomycin for Prevention of Recurrent Clostridioides difficile Infection: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2517834. doi: 10.1001/jamanetworkopen.2025.17834.
PMID: 40601321DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nasia Safdar, Professor
- Organization
- University of Wisconsin-Madison
Study Officials
- PRINCIPAL INVESTIGATOR
Nasia Safdar, MD PhD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2018
First Posted
March 12, 2018
Study Start
May 21, 2018
Primary Completion
July 6, 2023
Study Completion
July 6, 2023
Last Updated
May 25, 2025
Results First Posted
May 25, 2025
Record last verified: 2025-05