Overview
Screening to Prophylax Against Clostridium Difficile Infection -
Status:
Recruiting
Recruiting
Trial end date:
2022-09-01
2022-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in patients who are colonized with C. diff who are admitted to the hospital and need antibiotics for another infection.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
William Beaumont HospitalsTreatments:
Vancomycin
Criteria
Inclusion Criteria:1. Expected duration of admission sufficient to complete screening and enrollment
2. Age ≥18
3. Able to give informed consent
4. Initiated on one of the following antibiotics within the prior 72 hours with an
expected duration of at least 72 hours from enrollment: clindamycin, ampicillin,
ampicillin/sulbactam, amoxicillin, amoxicillin/clavulanate, moxifloxacin,
levofloxacin, piperacillin/tazobactam, or any cephalosporin
5. Maximum expected duration of antibiotics 8 weeks
6. Able to take oral study medications
7. Able to provide a stool sample during hospitalization or within 3 days of discharge
8. Reasonably expected to be able to complete follow up
Exclusion Criteria:
1. Chron's disease, ulcerative colitis, celiac disease, or other chronic diarrheal
illness
2. CDI within prior 90 days
3. Currently on metronidazole, oral vancomycin, rifaximin, fidaxomicin, or any other
antibiotic active against C. difficile
4. Current diarrhea
5. Current ileostomy, colostomy or other form of surgically disconnected gut such that
oral therapy would not be expected to reach the entire lumen of the gut
6. Pregnancy or breast feeding (determined prior to randomization)
7. Travel to an area of endemic diarrheal illness within the last 30 days
8. Life expectancy of less than 60 days
9. Known allergy to vancomycin
10. Participation with other research trials that could impact the results of this trial
within the last 30 days
11. Previously enrolled in this study