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

Who is this study for? Patients with C.Difficile Diarrhea
What treatments are being studied? Vancomycin
Status: Completed
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
United States
Wisconsin
University of Wisconsin-Madison
Madison
Medical College of Wisconsin
Milwaukee
Time Frame
Start Date: 2018-05-21
Completion Date: 2023-07-06
Participants
Target number of participants: 79
Treatments
Experimental: Vancomycin
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Placebo_comparator: Placebo
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Sponsors
Collaborators: Mayo Clinic, Medical College of Wisconsin, Agency for Healthcare Research and Quality (AHRQ), Henry Ford Hospital
Leads: University of Wisconsin, Madison

This content was sourced from clinicaltrials.gov