<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02237859</url>
  </required_header>
  <id_info>
    <org_study_id>2013-303</org_study_id>
    <secondary_id>DDI.FY14.01</secondary_id>
    <nct_id>NCT02237859</nct_id>
  </id_info>
  <brief_title>Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection</brief_title>
  <official_title>Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spectrum Health Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spectrum Health Hospitals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We are doing this research study to determine if taking vancomycin in addition to a&#xD;
      broad-spectrum antibiotic will decrease the chance of developing recurrent Clostridium&#xD;
      difficile infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine whether prophylactic use of oral vancomycin reduces the incidence of recurrent&#xD;
      Clostridium difficile infection (RCDI) in hospitalized patients admitted from their home or&#xD;
      another health care facility (HCF) who are exposed to concurrent broad spectrum antibiotics.&#xD;
&#xD;
      This is a randomized research study, which means that the treatment you get will be chosen by&#xD;
      chance, like flipping a coin. You will have a 50/50 chance of receiving one of the following:&#xD;
&#xD;
        1. Group 1 (Treatment Group): single daily dose of vancomycin in liquid form (study&#xD;
           medication).&#xD;
&#xD;
        2. Group 2 (Placebo Group): single daily dose of placebo (a placebo will look just like the&#xD;
           study medication, but contains no medication, only a substance like sterile water).&#xD;
&#xD;
      Depending on the group you are placed in (which is chosen by a computer), you will receive&#xD;
      either a daily dose of the study medication or a daily dose of the placebo for a total of ten&#xD;
      days. If you are discharged from the hospital prior to ten days, you will be given the study&#xD;
      medication to complete outside of the hospital with written instructions.&#xD;
&#xD;
      A member of the Research staff will monitor you daily during the 10 days of treatment for any&#xD;
      adverse reactions or any signs and symptoms of recurrent Clostridium difficile infection. If&#xD;
      you are discharged prior to ten days, the monitoring will take place via telephone call daily&#xD;
      until completion of the ten day treatment.&#xD;
&#xD;
      You will be contacted again by telephone at 1, 3, and 6 months after completion of the study&#xD;
      medication to inquire about your general health and any changes in health status.&#xD;
&#xD;
      Other medical information from your records and charts may also be collected by us for&#xD;
      purposes of review for this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of recurrent Clostridium difficile infection</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Clostridium Difficile Infection</condition>
  <arm_group>
    <arm_group_label>Vancomycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vancomycin 125 mg PO QD vs Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin</intervention_name>
    <description>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.</description>
    <arm_group_label>Vancomycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>fruit juice/placebo</intervention_name>
    <description>Placebo Group: Will receive similar volume of fruit juice/placebo for 10 days.</description>
    <arm_group_label>Vancomycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. In patients &gt;19 years of age&#xD;
&#xD;
          2. History of C. difficile diarrhea within 16 weeks and treated with Flagyl or Vancomycin&#xD;
             during last episode.&#xD;
&#xD;
          3. Patients started on antibiotics during current admission for any other indication at&#xD;
             any point of time during hospital course.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current diagnosis of CDI&#xD;
&#xD;
          2. First episode of CDI during this admission.&#xD;
&#xD;
          3. Allergy to Vancomycin or other known intolerance&#xD;
&#xD;
          4. Pregnant&#xD;
&#xD;
        h) Patient has received broad-spectrum antibiotics for more than 48 hours for this&#xD;
        admission j) Incarceration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Maternowski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spectrum Health Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spectrum Health Hospital</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary E Readwin, RN</last_name>
      <phone>616-486-2043</phone>
      <email>mary.readwin@spectrumhealth.org</email>
    </contact>
    <investigator>
      <last_name>Andrew P Maternowski, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spectrum Health Hospitals</investigator_affiliation>
    <investigator_full_name>Andrew Maternowski</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <keyword>cdiff</keyword>
  <keyword>vancomycin</keyword>
  <keyword>infection</keyword>
  <keyword>clostridium difficile</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Clostridium Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vancomycin</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>March 15, 2022</submitted>
    <returned>April 8, 2022</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02237859
org study id: 2013-303
secondary id: DDI.FY14.01
nct id: NCT02237859
lead sponsor: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: The incidence of recurrent Clostridium difficile infection
time frame: 2 years
arm group label: Vancomycin
arm group type: Experimental
description: Vancomycin 125 mg PO QD vs Placebo
intervention type: Drug
intervention name: Vancomycin
description: 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.
arm group label: Vancomycin
intervention type: Dietary Supplement
intervention name: fruit juice/placebo
description: Placebo Group: Will receive similar volume of fruit juice/placebo for 10 days.
arm group label: Vancomycin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Maternowski, MD
role: Principal Investigator
affiliation: Spectrum Health Hospitals
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Spectrum Health Hospitals
investigator full name: Andrew Maternowski
investigator title: Physician
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Clostridium Infections
mesh term: Vancomycin
submitted: March 15, 2022
returned: April 8, 2022