Phase 2
Completed N=79
Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
Recurrent Clostridium difficile infection · Clostridium Difficile Infection · CDI · C.Difficile Diarrhea
Source: ClinicalTrials.gov NCT03462459 ↗
Enrolled (actual)
79
Serious AEs
24.1%
Results posted
May 2025
Primary outcomePrimary: Recurrent Clostridium Difficile Infection (CDI) — 17; 24 Participants — p=0.22
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrent Clostridium Difficile Infection (CDI) |
17; 24 | 0.22 |
| SECONDARY Gut Microbiome Composition |
NA; NA | — |
| SECONDARY Vancomycin-resistant Enterococcus (VRE) Colonization in Stool Samples of Patients Receiving Vancomycin vs. Patients Receiving Placebo |
15; 6 | 0.10 |
| SECONDARY Determine Whether Clostridium Difficile Positivity on Any Stool Sample is a Predictor of CDI Recurrence. |
NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03462459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.