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

William Beaumont Hospitals

Status and phase: Completed; Phase 4

Conditions: Clostridium Difficile Infection

Treatments: Drug: Vancomycin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02996487

2016-254

Details and patient eligibility

About

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.

Full 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 polymerase chain reaction (PCR) test. 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 by mouth (PO) every 6 hours as prophylaxis against C. difficile for the duration of their antibiotic treatment +3 days.

Arm 2: Patients receive placebo by mouth (PO) every 6 hours for the duration of their antibiotic treatment +3 days.

Enrollment: 1,294 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,294 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin.

Treatment:

Other: Placebo

vancomycin

Active Comparator group

Description:

Vancomycin 125 mg by mouth every 6 hours

Treatment:

Drug: Vancomycin