Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection

NCT02237859 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2014-09-11

No results posted yet for this study

Summary

We are doing this research study to determine if taking vancomycin in addition to a broad-spectrum antibiotic will decrease the chance of developing recurrent Clostridium difficile infection.

Conditions

  • Clostridium Difficile Infection

Interventions

DRUG

Vancomycin

Vancomycin Group: Study participants started on a broad-spectrum antibiotic will be initiated on Vancomycin 125 mg PO QD within 48 hrs of the 1st dose of primary broad-spectrum antibiotic and continued to complete a 10 day course regardless of the duration of primary antibiotic. Dose of oral Vancomycin is 125 mg PO QD. Vancomycin liquid will be dissolved in fruit juice which is standard practice at Spectrum Health Hospitals. Both groups will continue in the study even if their broad spectrum antibiotic therapy is curtailed prior to 10 days.

DIETARY_SUPPLEMENT

fruit juice/placebo

Placebo Group: Will receive similar volume of fruit juice/placebo for 10 days.

Sponsors & Collaborators

  • Spectrum Health Hospitals

    lead OTHER

Principal Investigators

  • Andrew Maternowski, MD · Spectrum Health Hospitals

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02237859 on ClinicalTrials.gov