Screening to Prophylax Against Clostridium Difficile Infection -

Study Overview
=================
Brief 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.

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 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.

Official Title
-----------------
Screening to Prophylax Against Clostridium Difficile Infection

Conditions
-----------------
Clostridium Difficile Infection

Intervention / Treatment
-----------------
* Drug: Vancomycin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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. | Other: Placebo<br> <br> |
| Active Comparator: vancomycin<br>Vancomycin 125 mg by mouth every 6 hours | Drug: Vancomycin<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of CDI in inpatients receiving vancomycin prophylaxis vs. placebo who are on high-risk antibiotics and are colonized with toxigenic C. difficile. | Number of participants with CDI in this subgroup of patients as assessed by clinical presentation, 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 EIA, and clinical symptoms compatible with CDI. | 12 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of CDI in patients receiving vancomycin prophylaxis vs. placebo. | Number of participants with mild, moderate, severe or fulminant disease after treatment | 12 weeks after treatment | 
| The outcome of CDI in patients receiving vancomycin prophylaxis vs. placebo. | Number of participants who developed C difficile infection after treatment. | 12 weeks after treatment | 
| The prevalence of toxigenic C. difficile colonization among the inpatient population treated with high-risk antibiotics based on C. difficile PCR. | Number of participants who remained colonized with C. difficile after treatment | 12 weeks after treatment | 
| The incidence of CDI in patients initiated on high risk antibiotics who are not colonized with toxigenic C. difficile. | 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. | 12 weeks after antibiotics |