Screening to Prophylax Against Clostridium Difficile Infection - (StoP CDI)

  • STATUS
    Recruiting
  • End date
    Sep 10, 2023
  • participants needed
    2500
  • sponsor
    William Beaumont Hospitals
Updated on 10 March 2022
antibiotic therapy
antibiotics
vancomycin
cephalosporin
clostridium difficile
ampicillin/sulbactam

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.

Description

Screening to Prophylax against CDI (SToP CDI) is a prospective, single-center, double-blinded, randomized, placebo-controlled study of the effectiveness of vancomycin vs. placebo for preventing CDI in patients colonized with toxigenic C. difficile and receiving high-risk antibiotics. The investigators plan to screen 2500 patients to randomize 200.

Consented patients will have a stool sample collected and tested for presence of toxigenic C. difficile by PCR. Patients who test negative will simply be followed for development, severity and outcome of CDI. Patients who test positive (are colonized with C. difficile) will be randomized to one of two arms:

Arm 1: Patients receive 125 mg vancomycin PO q6 hours as prophylaxis against C. difficile for the duration of their antibiotic treatment +3 days.

Arm 2: Patients receive placebo PO q6 hours for the duration of their antibiotic treatment +3 days.

Details
Condition Clostridium Difficile Infection
Treatment Placebo, Vancomycin
Clinical Study IdentifierNCT02996487
SponsorWilliam Beaumont Hospitals
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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