Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection
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|ClinicalTrials.gov Identifier: NCT02237859|
Recruitment Status : Unknown
Verified September 2014 by Andrew Maternowski, Spectrum Health Hospitals.
Recruitment status was: Recruiting
First Posted : September 11, 2014
Last Update Posted : September 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Drug: Vancomycin Dietary Supplement: fruit juice/placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2016|
Vancomycin 125 mg PO QD vs Placebo
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.
Dietary Supplement: fruit juice/placebo
Placebo Group: Will receive similar volume of fruit juice/placebo for 10 days.
- The incidence of recurrent Clostridium difficile infection [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237859
|United States, Michigan|
|Spectrum Health Hospital||Recruiting|
|Grand Rapids, Michigan, United States, 49503|
|Contact: Mary E Readwin, RN 616-486-2043 firstname.lastname@example.org|
|Principal Investigator: Andrew P Maternowski, MD|
|Principal Investigator:||Andrew Maternowski, MD||Spectrum Health Hospitals|