Prospective Trial of Oral Vancomycin Therapy vs. Placebo for Prevention of CDI

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized, Double-Blind, Trial of Oral Vancomycin Therapy Compared to Placebo As Primary Prevention for C. Difficile-associated Infection (CDI)

Conditions
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CDI

Intervention / Treatment
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* Drug: Vancomycin 125 MG po BID


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Older patients (> 65 years of age), hospitalized for > 48 hours and treated with parenteral antimicrobial therapy for > 48 hours at CHI Creighton University Medical Center-Bergan Mercy will be eligible for enrollment. Exclusion Criteria: Patients diagnosed with CDI within the first 72 hours of hospitalization and/or diagnosed with CDI within the past 3 months Patients diagnosed with gastrointestinal infection other than CDI Patients who have received a solid-organ transplant in the past 12 months Females who are pregnant or immediately post-partum Patients admitted to the hospital with an opportunistic infection secondary to HIV-1 and CD4 cell count of < 200 cell/mm3 Patients receiving cancer chemotherapy or immune modulator drugs (i.e. Checkpoint inhibitors; PD-1/PD-L1 inhibitors; biologic DMARDs) as examples Patients being treated with ≥ 28 days of intravenous (IV) antimicrobials (complex S. aureus bacteremia, osteomyelitis, endocarditis)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vancomycin oral solution<br>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. | Drug: Vancomycin 125 MG po BID<br>* prevention to develop CDI during hospitalization<br>* Other names: placebo oral solution po BID;|
| Placebo Comparator: placebo oral solution<br>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. | Drug: Vancomycin 125 MG po BID<br>* prevention to develop CDI during hospitalization<br>* Other names: placebo oral solution po BID;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |