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

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ClinicalTrials.gov Identifier: NCT03462459
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : June 20, 2018
Sponsor:
Collaborators:
Indiana University
Medical College of Wisconsin
Agency for Healthcare Research and Quality (AHRQ)
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 90 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 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.


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 : December 31, 2021
Estimated Study Completion Date : December 31, 2021

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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 90 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 urine 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.
  • Patients who have received a fecal microbiota transplant 90 days prior to 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 ClinicalTrials.gov identifier (NCT number): NCT03462459


Contacts
Contact: Kendra Haight, RN 608-262-6560 khaight@wisc.edu
Contact: Michele L Zimbric, BS 608-265-8799 mzimbric@medicine.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Kendra L Haight, BSN RN    608-262-6560    khaight@wisc.edu   
Contact: Shelly L Zimbric, BS    608-265-8799    mlzimbri@wisc.edu   
Principal Investigator: Nasia Safdar, MD PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Indiana University
Medical College of Wisconsin
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Nasia Safdar, MD PhD University of Wisconsin, Madison
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
Study Protocol  [PDF] January 23, 2018
Informed Consent Form  [PDF] January 23, 2018


Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03462459     History of Changes
Other Study ID Numbers: 2017-0927
1R01HS025713-01 ( U.S. AHRQ Grant/Contract )
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents