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Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection

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ClinicalTrials.gov Identifier: NCT02237859
Recruitment Status : Unknown
Verified September 2014 by Andrew Maternowski, Spectrum Health Hospitals.
Recruitment status was:  Recruiting
First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Andrew Maternowski, Spectrum Health Hospitals

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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: Vancomycin Dietary Supplement: fruit juice/placebo Phase 4

Detailed Description:

To determine whether prophylactic use of oral vancomycin reduces the incidence of recurrent Clostridium difficile infection (RCDI) in hospitalized patients admitted from their home or another health care facility (HCF) who are exposed to concurrent broad spectrum antibiotics.

This is a randomized research study, which means that the treatment you get will be chosen by chance, like flipping a coin. You will have a 50/50 chance of receiving one of the following:

  1. Group 1 (Treatment Group): single daily dose of vancomycin in liquid form (study medication).
  2. Group 2 (Placebo Group): single daily dose of placebo (a placebo will look just like the study medication, but contains no medication, only a substance like sterile water).

Depending on the group you are placed in (which is chosen by a computer), you will receive either a daily dose of the study medication or a daily dose of the placebo for a total of ten days. If you are discharged from the hospital prior to ten days, you will be given the study medication to complete outside of the hospital with written instructions.

A member of the Research staff will monitor you daily during the 10 days of treatment for any adverse reactions or any signs and symptoms of recurrent Clostridium difficile infection. If you are discharged prior to ten days, the monitoring will take place via telephone call daily until completion of the ten day treatment.

You will be contacted again by telephone at 1, 3, and 6 months after completion of the study medication to inquire about your general health and any changes in health status.

Other medical information from your records and charts may also be collected by us for purposes of review for this study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection
Study Start Date : August 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vancomycin
Vancomycin 125 mg PO QD vs Placebo
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.




Primary Outcome Measures :
  1. The incidence of recurrent Clostridium difficile infection [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237859


Locations
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United States, Michigan
Spectrum Health Hospital Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Mary E Readwin, RN    616-486-2043    mary.readwin@spectrumhealth.org   
Principal Investigator: Andrew P Maternowski, MD         
Sponsors and Collaborators
Spectrum Health Hospitals
Investigators
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Principal Investigator: Andrew Maternowski, MD Spectrum Health Hospitals

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Responsible Party: Andrew Maternowski, Physician, Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT02237859     History of Changes
Other Study ID Numbers: 2013-303
DDI.FY14.01 ( Other Grant/Funding Number: Digestive Disease Institute )
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014

Keywords provided by Andrew Maternowski, Spectrum Health Hospitals:
cdiff
vancomycin
infection
clostridium difficile

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents