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

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: January 13, 2020

Interventions

  • Drug: Vancomycin 125 MG po BID
    • prevention to develop CDI during hospitalization

Arms, Groups and Cohorts

  • Active Comparator: vancomycin oral solution
    • 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 Comparator: placebo oral solution
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • number of enrolled patients who develop CDI during hospitalization assessed (“up to 3 month”)
    • Time Frame: during hospitalization through study completion, assessed up to 3 months
    • number of enrolled patient with CDI receiving oral vancomycin compared to placebo

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Creighton University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christopher Destache, Professor – Creighton University

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