A Randomized Controlled Trial of Oral Vancomycin for Preventing Recurrent Clostridium difficile Infection

M
Monika Fischer, MD

Primary Investigator

Not Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study

This study will determine the efficacy and safety of prophylaxis with oral vancomycin in patients with history of CDI within the past 90 days who now require non-CDI antibiotic therapy in preventing recurrent CDI.

Detailed description of study

The purpose of this study is to evaluate the efficacy of oral vancomycin prophylaxis for preventing recurrent Clostridium difficile infection (CDI) in patients who have experienced an initial episode of CDI in the last 90 days and are receiving antibiotics for a non-CDI condition

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Clostridium difficile Infection,clostridium difficile infection
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
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 (hormonal or barrier method of birth control; abstinence) prior to randomization, for the duration of study participation, and for 4 weeks following completion of study treatment
Exclusion Criteria
History of hypersensitivity or allergy to oral vancomycin
Current use of oral vancomycin
Patients who are on concurrent treatment with metronidazole or tetracycline monotherapy for any indication
Diagnosed with inflammatory bowel disorder (e.g. Crohn?s disease), or bacterial gastrointestinal infection caused by agents other than C. difficile (e.g. Salmonella sp.), toxic megacolon and/or known small bowel ileus
Inability (e.g. dysphagia) to or unwilling to swallow capsules
Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy
History of total colectomy or bariatric surgery
Enrolled in another clinical trial with investigational drugs within 30 days prior to randomization
Women who are pregnant or breast-feeding
Diarrhea (3 or more loose stools in a 24 hour period) at enrollment
Patient who received fecal microbiota transplant in 90 day window prior to enrollment


Additional Information:
Participants will be paid for their participation.

Updated on 01 Aug 2024. Study ID: 1803671272

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