<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/NCT02996487</url>
  </required_header>
  <id_info>
    <org_study_id>2016-254</org_study_id>
    <nct_id>NCT02996487</nct_id>
  </id_info>
  <brief_title>Screening to Prophylax Against Clostridium Difficile Infection -</brief_title>
  <acronym>StoP CDI</acronym>
  <official_title>Screening to Prophylax Against Clostridium Difficile Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Beaumont Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>William Beaumont Hospitals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in&#xD;
      patients who are colonized with C. diff who are admitted to the hospital and need antibiotics&#xD;
      for another infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Screening to Prophylax against CDI (SToP CDI) is a prospective, single-center,&#xD;
      double-blinded, randomized, placebo-controlled study of the effectiveness of vancomycin vs.&#xD;
      placebo for preventing CDI in patients colonized with toxigenic C. difficile and receiving&#xD;
      high-risk antibiotics. The investigators plan to screen 2500 patients to randomize 200.&#xD;
&#xD;
      Consented patients will have a stool sample collected and tested for presence of toxigenic C.&#xD;
      difficile by PCR. Patients who test negative will simply be followed for development,&#xD;
      severity and outcome of CDI. Patients who test positive (are colonized with C. difficile)&#xD;
      will be randomized to one of two arms:&#xD;
&#xD;
      Arm 1: Patients receive 125 mg vancomycin PO q6 hours as prophylaxis against C. difficile for&#xD;
      the duration of their antibiotic treatment +3 days.&#xD;
&#xD;
      Arm 2: Patients receive placebo PO q6 hours for the duration of their antibiotic treatment +3&#xD;
      days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">June 28, 2023</completion_date>
  <primary_completion_date type="Actual">June 28, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of CDI in inpatients receiving vancomycin prophylaxis vs. placebo who are on high-risk antibiotics and are colonized with toxigenic C. difficile.</measure>
    <time_frame>12 weeks after treatment</time_frame>
    <description>Number of participants with CDI in this subgroup of patients as assessed by clinical presentation, PCR testing of stool, and EIA test for production of toxins. Patients are considered to have CDI if they have a positive PCR test, a positive toxin EIA, and clinical symptoms compatible with CDI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The severity of CDI in patients receiving vancomycin prophylaxis vs. placebo.</measure>
    <time_frame>12 weeks after treatment</time_frame>
    <description>Number of participants with mild, moderate, severe or fulminant disease after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The outcome of CDI in patients receiving vancomycin prophylaxis vs. placebo.</measure>
    <time_frame>12 weeks after treatment</time_frame>
    <description>Number of participants who developed C difficile infection after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The prevalence of toxigenic C. difficile colonization among the inpatient population treated with high-risk antibiotics based on C. difficile PCR.</measure>
    <time_frame>12 weeks after treatment</time_frame>
    <description>Number of participants who remained colonized with C. difficile after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of CDI in patients initiated on high risk antibiotics who are not colonized with toxigenic C. difficile.</measure>
    <time_frame>12 weeks after antibiotics</time_frame>
    <description>Number of participants who developed CDI in this subgroup of patients as assessed by clinical presentation and PCR testing of stool. Patients are considered to have CDI if they have a positive PCR test and clinical symptoms compatible with CDI.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1295</enrollment>
  <condition>Clostridium Difficile Infection</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vancomycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vancomycin 125 mg by mouth every 6 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin</intervention_name>
    <arm_group_label>vancomycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Expected duration of admission sufficient to complete screening and enrollment&#xD;
&#xD;
          2. Age ≥18&#xD;
&#xD;
          3. Able to give informed consent&#xD;
&#xD;
          4. Initiated on one of the following antibiotics within the prior 72 hours with an&#xD;
             expected duration of at least 72 hours from enrollment: clindamycin, ampicillin,&#xD;
             ampicillin/sulbactam, amoxicillin, amoxicillin/clavulanate, moxifloxacin,&#xD;
             levofloxacin, piperacillin/tazobactam, or any cephalosporin&#xD;
&#xD;
          5. Maximum expected duration of antibiotics 8 weeks&#xD;
&#xD;
          6. Able to take oral study medications&#xD;
&#xD;
          7. Able to provide a stool sample during hospitalization or within 3 days of discharge&#xD;
&#xD;
          8. Reasonably expected to be able to complete follow up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Chron's disease, ulcerative colitis, celiac disease, or other chronic diarrheal&#xD;
             illness&#xD;
&#xD;
          2. CDI within prior 90 days&#xD;
&#xD;
          3. Currently on metronidazole, oral vancomycin, rifaximin, fidaxomicin, or any other&#xD;
             antibiotic active against C. difficile&#xD;
&#xD;
          4. Current diarrhea&#xD;
&#xD;
          5. Current ileostomy, colostomy or other form of surgically disconnected gut such that&#xD;
             oral therapy would not be expected to reach the entire lumen of the gut&#xD;
&#xD;
          6. Pregnancy or breast feeding (determined prior to randomization)&#xD;
&#xD;
          7. Travel to an area of endemic diarrheal illness within the last 30 days&#xD;
&#xD;
          8. Life expectancy of less than 60 days&#xD;
&#xD;
          9. Known allergy to vancomycin&#xD;
&#xD;
         10. Participation with other research trials that could impact the results of this trial&#xD;
             within the last 30 days&#xD;
&#xD;
         11. Previously enrolled in this study&#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>Matthew Sims, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beaumont Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Dearborn</city>
        <state>Michigan</state>
        <zip>48124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Matthew Sims, MD, PhD</investigator_full_name>
    <investigator_title>Director Infectious Disease Research, Beaumont Health; Professor of Internal Medicine and Foundational Medical Studies, OUWB School of Medicine</investigator_title>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 20, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT02996487/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02996487
org study id: 2016-254
nct id: NCT02996487
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in
      patients who are colonized with C. diff who are admitted to the hospital and need antibiotics
      for another infection.
Screening to Prophylax against CDI (SToP CDI) is a prospective, single-center,
      double-blinded, randomized, placebo-controlled study of the effectiveness of vancomycin vs.
      placebo for preventing CDI in patients colonized with toxigenic C. difficile and receiving
      high-risk antibiotics. The investigators plan to screen 2500 patients to randomize 200.

      Consented patients will have a stool sample collected and tested for presence of toxigenic C.
      difficile by PCR. Patients who test negative will simply be followed for development,
      severity and outcome of CDI. Patients who test positive (are colonized with C. difficile)
      will be randomized to one of two arms:

      Arm 1: Patients receive 125 mg vancomycin PO q6 hours as prophylaxis against C. difficile for
      the duration of their antibiotic treatment +3 days.

      Arm 2: Patients receive placebo PO q6 hours for the duration of their antibiotic treatment +3
      days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: The incidence of CDI in inpatients receiving vancomycin prophylaxis vs. placebo who are on high-risk antibiotics and are colonized with toxigenic C. difficile.
time frame: 12 weeks after treatment
description: Number of participants with CDI in this subgroup of patients as assessed by clinical presentation, PCR testing of stool, and EIA test for production of toxins. Patients are considered to have CDI if they have a positive PCR test, a positive toxin EIA, and clinical symptoms compatible with CDI.
measure: The severity of CDI in patients receiving vancomycin prophylaxis vs. placebo.
time frame: 12 weeks after treatment
description: Number of participants with mild, moderate, severe or fulminant disease after treatment
measure: The outcome of CDI in patients receiving vancomycin prophylaxis vs. placebo.
time frame: 12 weeks after treatment
description: Number of participants who developed C difficile infection after treatment.
measure: The prevalence of toxigenic C. difficile colonization among the inpatient population treated with high-risk antibiotics based on C. difficile PCR.
time frame: 12 weeks after treatment
description: Number of participants who remained colonized with C. difficile after treatment
measure: The incidence of CDI in patients initiated on high risk antibiotics who are not colonized with toxigenic C. difficile.
time frame: 12 weeks after antibiotics
description: Number of participants who developed CDI in this subgroup of patients as assessed by clinical presentation and PCR testing of stool. Patients are considered to have CDI if they have a positive PCR test and clinical symptoms compatible with CDI.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin.
arm group label: vancomycin
arm group type: Active Comparator
description: Vancomycin 125 mg by mouth every 6 hours
intervention type: Drug
intervention name: Vancomycin
arm group label: vancomycin
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew Sims, MD PhD
role: Principal Investigator
affiliation: Beaumont Health
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Matthew Sims, MD, PhD
investigator title: Director Infectious Disease Research, Beaumont Health; Professor of Internal Medicine and Foundational Medical Studies, OUWB School of Medicine
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Clostridium Infections
mesh term: Vancomycin
sharing ipd: No
provided document: 