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

Sponsor
Creighton University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04241744
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
2.5
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vancomycin 125 MG po BID
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Masking Description:
placebo controlled
Primary Purpose:
Prevention
Official Title:
Prospective, Randomized, Double-Blind, Trial of Oral Vancomycin Therapy Compared to Placebo As Primary Prevention for C. Difficile-associated Infection (CDI)
Actual Study Start Date :
Oct 29, 2019
Actual Primary Completion Date :
Jan 13, 2020
Actual Study Completion Date :
Jan 13, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Vancomycin 125 MG po BID
prevention to develop CDI during hospitalization
Other Names:
  • placebo oral solution po BID

    		•
    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.

    Drug: Vancomycin 125 MG po BID
    prevention to develop CDI during hospitalization
    Other Names:
  • placebo oral solution po BID

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of enrolled patients who develop CDI during hospitalization assessed ("up to 3 month") [during hospitalization through study completion, assessed up to 3 months]

      number of enrolled patient with CDI receiving oral vancomycin compared to placebo

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Creighton University Medical Center - Bergan Mercy Omaha Nebraska United States 68124

    Sponsors and Collaborators

    • Creighton University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christopher Destache, Professor, Creighton University
    ClinicalTrials.gov Identifier:
    NCT04241744
    Other Study ID Numbers:
    • 2000200-01
    First Posted:
    Jan 27, 2020
    Last Update Posted:
    Jan 27, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Vancomycin

    Study Results

    No Results Posted as of Jan 27, 2020