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

Creighton University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Conditions

CDI

Interventions

Vancomycin 125 MG po BIDDRUG

prevention to develop CDI during hospitalization

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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: 1. Patients diagnosed with CDI within the first 72 hours of hospitalization and/or diagnosed with CDI within the past 3 months 2. Patients diagnosed with gastrointestinal infection other than CDI 3. Patients who have received a solid-organ transplant in the past 12 months 4. Females who are pregnant or immediately post-partum 5. Patients admitted to the hospital with an opportunistic infection secondary to HIV-1 and CD4 cell count of \< 200 cell/mm3 6. Patients receiving cancer chemotherapy or immune modulator drugs (i.e. Checkpoint inhibitors; PD-1/PD-L1 inhibitors; biologic DMARDs) as examples 7. Patients being treated with ≥ 28 days of intravenous (IV) antimicrobials (complex S. aureus bacteremia, osteomyelitis, endocarditis)

Locations (1)

Creighton University Medical Center - Bergan Mercy

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

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

Time frame: during hospitalization through study completion, assessed up to 3 months

Data from ClinicalTrials.gov

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