Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection
Vancomycin
+ fruit juice/placebo
Bacterial Infections and Mycoses+2
+ Bacterial Infections
+ Clostridium Infections
Prevention Study
Summary
Study start date: August 1, 2014
Actual date on which the first participant was enrolled.To determine whether prophylactic use of oral vancomycin reduces the incidence of recurrent Clostridium difficile infection (RCDI) in hospitalized patients admitted from their home or another health care facility (HCF) who are exposed to concurrent broad spectrum antibiotics. This is a randomized research study, which means that the treatment you get will be chosen by chance, like flipping a coin. You will have a 50/50 chance of receiving one of the following: 1. Group 1 (Treatment Group): single daily dose of vancomycin in liquid form (study medication). 2. Group 2 (Placebo Group): single daily dose of placebo (a placebo will look just like the study medication, but contains no medication, only a substance like sterile water). Depending on the group you are placed in (which is chosen by a computer), you will receive either a daily dose of the study medication or a daily dose of the placebo for a total of ten days. If you are discharged from the hospital prior to ten days, you will be given the study medication to complete outside of the hospital with written instructions. A member of the Research staff will monitor you daily during the 10 days of treatment for any adverse reactions or any signs and symptoms of recurrent Clostridium difficile infection. If you are discharged prior to ten days, the monitoring will take place via telephone call daily until completion of the ten day treatment. You will be contacted again by telephone at 1, 3, and 6 months after completion of the study medication to inquire about your general health and any changes in health status. Other medical information from your records and charts may also be collected by us for purposes of review for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.140 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. In patients \>19 years of age 2. History of C. difficile diarrhea within 16 weeks and treated with Flagyl or Vancomycin during last episode. 3. Patients started on antibiotics during current admission for any other indication at any point of time during hospital course. Exclusion Criteria: 1. Current diagnosis of CDI 2. First episode of CDI during this admission. 3. Allergy to Vancomycin or other known intolerance 4. Pregnant h) Patient has received broad-spectrum antibiotics for more than 48 hours for this admission j) Incarceration
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location