Screening to Prophylax Against Clostridium Difficile Infection -

Completed · Phase 4 · Has a placebo group

Conditions studied: Clostridium Difficile Infection

In brief

The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in patients who are colonized with C. difficile who are admitted to the hospital and need antibiotics for another infection.

Key facts

Study ID

NCT02996487

Run by

Corewell Health East

People needed

1294

Starts

2016-12-19

Expected to finish

2023-06-28

Last updated by the study team

2024-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Expected duration of admission sufficient to complete screening and enrollment
• Age ≥18
• Able to give informed consent
• 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
• Maximum expected duration of antibiotics 8 weeks
• Able to take oral study medications
• Able to provide a stool sample during hospitalization or within 3 days of discharge
• Reasonably expected to be able to complete follow up

You may not qualify if…

• Chron's disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness
• CDI within prior 90 days
• Currently on metronidazole, oral vancomycin, rifaximin, fidaxomicin, or any other antibiotic active against C. difficile
• Current diarrhea
• 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
• Pregnancy or breast feeding (determined prior to randomization)
• Travel to an area of endemic diarrheal illness within the last 30 days
• Life expectancy of less than 60 days
• Known allergy to vancomycin
• Participation with other research trials that could impact the results of this trial within the last 30 days
• Previously enrolled in this study

Where it is running

• William Beaumont Hospital — Dearborn, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• William Beaumont Hospital — Troy, Michigan, United States

Full record on ClinicalTrials.gov

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