Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection
Primary Purpose
Clostridium Difficile Infection
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vancomycin
fruit juice/placebo
Sponsored by
About this trial
This is an interventional prevention trial for Clostridium Difficile Infection focused on measuring cdiff, vancomycin, infection, clostridium difficile
Eligibility Criteria
Inclusion Criteria:
- In patients >19 years of age
- History of C. difficile diarrhea within 16 weeks and treated with Flagyl or Vancomycin during last episode.
- Patients started on antibiotics during current admission for any other indication at any point of time during hospital course.
Exclusion Criteria:
- Current diagnosis of CDI
- First episode of CDI during this admission.
- Allergy to Vancomycin or other known intolerance
- Pregnant
h) Patient has received broad-spectrum antibiotics for more than 48 hours for this admission j) Incarceration
Sites / Locations
- Spectrum Health HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vancomycin
Arm Description
Vancomycin 125 mg PO QD vs Placebo
Outcomes
Primary Outcome Measures
The incidence of recurrent Clostridium difficile infection
Secondary Outcome Measures
Full Information
NCT ID
NCT02237859
First Posted
September 3, 2014
Last Updated
September 10, 2014
Sponsor
Spectrum Health Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT02237859
Brief Title
Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection
Official Title
Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spectrum Health Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We are doing this research study to determine if taking vancomycin in addition to a broad-spectrum antibiotic will decrease the chance of developing recurrent Clostridium difficile infection.
Detailed Description
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:
Group 1 (Treatment Group): single daily dose of vancomycin in liquid form (study medication).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
Keywords
cdiff, vancomycin, infection, clostridium difficile
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
N/A
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vancomycin
Arm Type
Experimental
Arm Description
Vancomycin 125 mg PO QD vs Placebo
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
Vancomycin Group: Study participants started on a broad-spectrum antibiotic will be initiated on Vancomycin 125 mg PO QD within 48 hrs of the 1st dose of primary broad-spectrum antibiotic and continued to complete a 10 day course regardless of the duration of primary antibiotic. Dose of oral Vancomycin is 125 mg PO QD. Vancomycin liquid will be dissolved in fruit juice which is standard practice at Spectrum Health Hospitals. Both groups will continue in the study even if their broad spectrum antibiotic therapy is curtailed prior to 10 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
fruit juice/placebo
Intervention Description
Placebo Group: Will receive similar volume of fruit juice/placebo for 10 days.
Primary Outcome Measure Information:
Title
The incidence of recurrent Clostridium difficile infection
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In patients >19 years of age
History of C. difficile diarrhea within 16 weeks and treated with Flagyl or Vancomycin during last episode.
Patients started on antibiotics during current admission for any other indication at any point of time during hospital course.
Exclusion Criteria:
Current diagnosis of CDI
First episode of CDI during this admission.
Allergy to Vancomycin or other known intolerance
Pregnant
h) Patient has received broad-spectrum antibiotics for more than 48 hours for this admission j) Incarceration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Maternowski, MD
Organizational Affiliation
Spectrum Health Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spectrum Health Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary E Readwin, RN
Phone
616-486-2043
Email
mary.readwin@spectrumhealth.org
First Name & Middle Initial & Last Name & Degree
Andrew P Maternowski, MD
12. IPD Sharing Statement
Learn more about this trial
Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection
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