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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    150
  • sponsor
    University of Wisconsin, Madison
Updated on 28 February 2022
antibiotic therapy
antibiotics
vancomycin
clostridium difficile
oral vancomycin

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.

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.

Details
Condition Recurrent Clostridium Difficile Infection, Clostridium Difficile Infection, CDI, C.Difficile Diarrhea, C. Diff Colitis, C.Difficile Colitis
Treatment Placebo, Vancomycin
Clinical Study IdentifierNCT03462459
SponsorUniversity of Wisconsin, Madison
Last Modified on28 February 2022

Eligibility

Yes No Not Sure

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
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