Screening to Prophylax Against Clostridium Difficile Infection -

Phase 4

Completed

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
vancomycin	Vancomycin	Vancomycin 125 mg by mouth every 6 hours

Primary Outcome Measures

Name	Time	Method
The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile.	12 weeks after treatment	Number of participants with CDI in this subgroup of patients as assessed by clinical presentation, polymerase chain reaction (PCR) testing of stool, and EIA test for production of toxins. Patients are considered to have CDI if they have a positive PCR test, a positive toxin enzyme immunoassay (EIA) test, and clinical symptoms compatible with CDI. This outcome is only applicable to the two randomized arms.

Secondary Outcome Measures

Name	Time	Method
The Severity of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo.	12 weeks after treatment	Number of randomized participants with mild, moderate, severe or fulminant disease after treatment. This outcome is only applicable to the two randomized arms.
The Outcome of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo.	12 weeks after treatment	Number of participants who developed C difficile infection after treatment. This outcome is only applicable to the two randomized arms.
The Prevalence of Toxigenic C. Difficile Colonization Among the Inpatient Population Treated With High-risk Antibiotics Based on C. Difficile PCR.	12 weeks after treatment	Number of participants who remained colonized with C. difficile after treatment. This outcome is only applicable to the two randomized arms.
The Incidence of CDI in Patients Initiated on High Risk Antibiotics Who Are Not Colonized With Toxigenic C. Difficile.	12 weeks after antibiotics	Number of participants who developed CDI in this subgroup of patients as assessed by clinical presentation and PCR testing of stool. Patients are considered to have CDI if they have a positive PCR test and clinical symptoms compatible with CDI.