Recruiting

Vancomycin

Sponsor:

Spectrum Health Hospitals

Code:

NCT02237859

Conditions

Clostridium Difficile Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vancomycin

fruit juice/placebo

Study Details

Brief 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

Study ID

NCT02237859

Start date

Aug, 2014

Status verified date

Sep, 2014

Completion date

Aug, 2016

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. In patients >19 years of age
2. History of C. difficile diarrhea within 16 weeks and treated with Flagyl or Vancomycin during last episode.
3. Patients started on antibiotics during current admission for any other indication at any point of time during hospital course.

Exclusion Criteria:

1. Current diagnosis of CDI
2. First episode of CDI during this admission.
3. Allergy to Vancomycin or other known intolerance
4. Pregnant

h) Patient has received broad-spectrum antibiotics for more than 48 hours for this admission j) Incarceration

Study Design

Enrollment

140 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Vancomycin

Vancomycin 125 mg PO QD vs Placebo

Interventions

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.

fruit juice/placebo

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

Primary outcome measure

  • The incidence of recurrent Clostridium difficile infection [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

Spectrum Health Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Mary E Readwin, RN

616-486-2043mary.readwin@spectrumhealth.org

Principal Investigator:

Andrew P Maternowski, MD

More Information

Sponsor

Spectrum Health Hospitals

Last update posted

Sep 11, 2014

Last verified

Sep, 2014

Keywords

  • cdiff
  • vancomycin
  • infection
  • clostridium difficile

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Spectrum Health Hospitals on 2014-09-11.