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

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

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 Overview

• Status: Withdrawn
• Conditions: CDI
• Intervention / Treatment: Drug: Vancomycin 125 MG po BID

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Creighton University Medical Center - Bergan Mercy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Creighton University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 29, 2019
• Primary Completion (ACTUAL): January 13, 2020
• Study Completion (ACTUAL): January 13, 2020

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (ACTUAL): January 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: 2000200-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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