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difficulty enrolling patients
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The purpose of this research study is to determine in patients receiving intravenous (IV) antibiotic(s), if giving oral vancomycin therapy will prevent C. difficile-associated infection (commonly called CDI). Oral vancomycin is an antibiotic that is commonly used to treat CDI. The investigators want to study if using this drug can prevent the development of CDI while you are in the hospital receiving IV antibiotics. The key risk factors for developing CDI are age and IV antibiotic therapy. CDI is an infection in your colon caused by an organism called Clostridium difficile (or C. diff for short) that causes diarrhea. Up to 12% of hospital-acquired infections have been reported to be CDI. It can lead to longer hospital stays and more costs associated with the hospital stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vancomycin oral solution | Active Comparator | vancomycin oral solution will be administered to consented patients >65 years of age receiving IV antimicrobial(s) for a bacterial infection twice daily while hospitalized. |
|
| placebo oral solution | Placebo Comparator | placebo oral solution will be administered to consented patients >65 years of age receiving IV antimicrobial(s) for a bacterial infection twice daily while hospitalized. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin 125 MG po BID | Drug | prevention to develop CDI during hospitalization |
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| Measure | Description | Time Frame |
|---|---|---|
| number of enrolled patients who develop CDI during hospitalization assessed ("up to 3 month") | number of enrolled patient with CDI receiving oral vancomycin compared to placebo | during hospitalization through study completion, assessed up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Creighton University Medical Center - Bergan Mercy | Omaha | Nebraska | 68124 | United States |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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placebo controlled
| D000602 |
| Amino Acids, Peptides, and Proteins |