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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03462459
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : August 16, 2021
Medical College of Wisconsin
Agency for Healthcare Research and Quality (AHRQ)
Henry Ford Hospital
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Recurrent Clostridium Difficile Infection Clostridium Difficile Infection CDI C.Difficile Diarrhea C. Diff Colitis C.Difficile Colitis Drug: Vancomycin Drug: Placebo Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vancomycin
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Drug: Vancomycin
Vancomycin capsule, 125 mg
Other Names:
  • Vancomycin Hydrochloride
  • Vancocin

Placebo Comparator: Placebo
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Drug: Placebo
Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule

Primary Outcome Measures :
  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 Outcome Measures :
  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 patients receiving vancomycin vs. 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 all patients and determine whether oral vancomycin increases the VRE colonization rate.

  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03462459

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Contact: Joseph Perzynski, BSW 608-265-8799
Contact: Michele L Zimbric, BS 608-265-8799

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United States, Minnesota
Division of Gastroenterology & Hepatology, Mayo clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Rebecca Hotschulte    507-284-9709   
Principal Investigator: Sahil Khanna, MBBS, MS         
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Kendra L Haight, BSN RN    608-262-6560   
Contact: Shelly L Zimbric, BS    608-265-8799   
Principal Investigator: Nasia Safdar, MD PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Medical College of Wisconsin
Agency for Healthcare Research and Quality (AHRQ)
Henry Ford Hospital
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Principal Investigator: Nasia Safdar, MD PhD University of Wisconsin, Madison
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
Study Protocol  [PDF] October 10, 2019
Informed Consent Form  [PDF] October 10, 2019

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Responsible Party: University of Wisconsin, Madison Identifier: NCT03462459    
Other Study ID Numbers: 2017-0927
1R01HS025713-01 ( U.S. AHRQ Grant/Contract )
A534265 ( Other Identifier: UW, Madison )
SMPH/MEDICINE/INFECT DIS ( Other Identifier: UW, Madison )
Protocol ver 6, 18 Nov 2020 ( Other Identifier: UW Madison )
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: August 16, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Wisconsin, Madison:
Oral vancomycin
Additional relevant MeSH terms:
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Communicable Diseases
Clostridium Infections
Enterocolitis, Pseudomembranous
Disease Attributes
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Signs and Symptoms, Digestive
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Anti-Bacterial Agents
Anti-Infective Agents