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Completed

NCT Number: NCT03462459

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin-Madison, Madison, Wisconsin, United States

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About this study

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 impacts patients' gastrointestinal microbiome and composition.

Patients with a history of past CDI who are receiving antibiotics for a non-CDI condition will be invited to participate. Approximately half of the participants will receive a low-dose capsule of vancomycin and half will receive a placebo. Participants will continue taking the vancomycin/placebo for 5 days after their prescribed antibiotics end.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vancomycin

Drug

Vancomycin capsule, 125 mg

Other names: Vancomycin Hydrochloride, Vancocin

Placebo

Drug

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

Primary outcomes

  1. Recurrent Clostridium Difficile Infection (CDI)

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Gut Microbiome Composition

    Time frame: 8 weeks

    Study how the gut microbiome is altered in patients receiving vancomycin treatment compared to placebo.

  2. Vancomycin-resistant Enterococcus (VRE) Colonization in Stool Samples of Patients Receiving Vancomycin vs. Patients Receiving Placebo

    Time frame: 8 weeks

    Low-dose exposure to vancomycin and VRE infection has not been studied. We will examine the incidence of VRE colonization in stool samples of all patients and determine whether oral vancomycin increases the VRE colonization rate, which has a negative impact on the overall health of patients being treated with vancomycin for C. difficile infection.

  3. Determine Whether Clostridium Difficile Positivity on Any Stool Sample is a Predictor of CDI Recurrence.

    Time frame: 8 weeks

    Stool samples will be tested at baseline, at the last dose date of vancomycin or placebo, at approximately 8 weeks following the last dose of vancomycin or placebo, and as indicated for diarrhea symptoms. Samples will be collected and tested for the presence of Clostridium difficile.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Henry Ford Hospital
  • Mayo Clinic
  • Medical College of Wisconsin

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2018
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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