<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/NCT01734694</url>
  </required_header>
  <id_info>
    <org_study_id>7089</org_study_id>
    <nct_id>NCT01734694</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients</brief_title>
  <acronym>STOP-NT</acronym>
  <official_title>Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</source>
  <brief_summary>
    <textblock>
      For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of&#xD;
      vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed&#xD;
      and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical&#xD;
      concern. This may be due to various reasons, including new dosing recommendations as well as&#xD;
      an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity.&#xD;
      This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin&#xD;
      use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Independent biostatistician recommended early termination of the trial due to low probability&#xD;
    of success.&#xD;
  </why_stopped>
  <start_date type="Actual">October 2011</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Individuals With Nephrotoxicity</measure>
    <time_frame>Day 1 and daily serum creatinine assessment up to date of discharge from hospital, and a median of 7 days.</time_frame>
    <description>Increase in SCr of 0.5 mg/dL or 50% above baseline for at least two consecutive days while on the study drug and through discharge from hospital.&#xD;
This measure will be reported as proportion of patients with nephrotoxicity within each group in relation to the number of patients in each group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Individuals With Acute Kidney Injury Network Modified Definition of Nephrotoxicity</measure>
    <time_frame>Day 1 and daily serum creatinine assessment up to date of discharge, and a median of 7 days.</time_frame>
    <description>An abrupt (within 48 hour) reduction in kidney function with one or more of the following 1) Increase in SCr ≥ 0.3 mg/dL 2) Increase SCr ≥ 50% or 3) Decreased urine output (&lt; 0.5 ml/kg/hr x 6 hrs) while on the study drug.&#xD;
This measure will be reported as proportion of patients with acute kidney injury within each group in relation to the number of patients in each group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Individuals With Clinical Success</measure>
    <time_frame>Daily assessment of signs and symptoms of infection, and a median of 7 days.</time_frame>
    <description>Clinical success is a composite endpoint of those patients with clinical cure or improvement in clinical signs and symptoms of infection (i.e. SIRS criteria, and microbiology) while on the study drug.&#xD;
This measure will be reported as the proportion of patients with clinical success in each group compared to the the total number of patients in the group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Health Care Associated Pneumonia</condition>
  <condition>Osteomyelitis/Septic Arthritis</condition>
  <condition>Endocarditis</condition>
  <condition>Bacteremia</condition>
  <condition>Acute Bacterial Skin and Skin Structure Infections</condition>
  <arm_group>
    <arm_group_label>Vancomycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin</intervention_name>
    <description>Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;&#xD;
Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;</description>
    <arm_group_label>Vancomycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ceftaroline</intervention_name>
    <description>Dose based on package insert labeling&#xD;
CrCL &gt; 50 mL/min: 600 mg IV q12h&#xD;
CrCL 31-50 mL/min: 400 mg q12h&#xD;
CrCL 15-30 mL/min: 300 mg q12h&#xD;
CrCL &lt; 15mL/min: 200 mg q12h;</description>
    <arm_group_label>Comparator</arm_group_label>
    <other_name>Teflaro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daptomycin</intervention_name>
    <description>Dose based on renal function and literature dosing recommendations&#xD;
CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h&#xD;
CrCL &lt; 30 mL/min: 6 - 10 mg/kg IV q48h</description>
    <arm_group_label>Comparator</arm_group_label>
    <other_name>Cubicin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Linezolid</intervention_name>
    <description>600 mg IV/PO q12h</description>
    <arm_group_label>Comparator</arm_group_label>
    <other_name>Zyvox</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years or older&#xD;
&#xD;
          -  Receiving intravenous vancomycin for the treatment of healthcare associated pneumonia,&#xD;
             osteomyelitis/septic arthritis, endocarditis/bacteremia, or acute bacterial skin and&#xD;
             skin structure infections&#xD;
&#xD;
          -  Expected to receive vancomycin for at least 72 hours and are within the first 72 hours&#xD;
             of therapy&#xD;
&#xD;
          -  Have at least two or more of the following risk factors for drug-induced&#xD;
             nephrotoxicity: a) receipt high-dose vancomycin therapy (greater than or equal to four&#xD;
             grams per day) b) receipt of vasopressors c) receipt of nephrotoxic drugs (i.e.&#xD;
             aminoglycosides, furosemide, acyclovir, amphotericin b, colistin, and intravenous&#xD;
             contrast dye) d) pre-existing renal dysfunction (i.e. SCr greater than or equal to 1.5&#xD;
             mg/dL).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  End-stage renal disease&#xD;
&#xD;
          -  Receipt of more than 4 grams of vancomycin prior to enrollment on current admission&#xD;
&#xD;
          -  Absolute neutrophil count &lt; 1000/mm3&#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>Jose Vazquez, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry Ford Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <results_first_submitted>March 15, 2023</results_first_submitted>
  <results_first_submitted_qc>April 13, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 3, 2023</results_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Jose Vazquez</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacteremia</mesh_term>
    <mesh_term>Osteomyelitis</mesh_term>
    <mesh_term>Arthritis, Infectious</mesh_term>
    <mesh_term>Healthcare-Associated Pneumonia</mesh_term>
    <mesh_term>Endocarditis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vancomycin</mesh_term>
    <mesh_term>Linezolid</mesh_term>
    <mesh_term>Daptomycin</mesh_term>
    <mesh_term>Ceftaroline fosamil</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Vancomycin</title>
          <description>Vancomycin: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;&#xD;
Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;</description>
        </group>
        <group group_id="P2">
          <title>Comparator</title>
          <description>Ceftaroline: Dose based on package insert labeling&#xD;
CrCL &gt; 50 mL/min: 600 mg IV q12h&#xD;
CrCL 31-50 mL/min: 400 mg q12h&#xD;
CrCL 15-30 mL/min: 300 mg q12h&#xD;
CrCL &lt; 15mL/min: 200 mg q12h;&#xD;
Daptomycin: Dose based on renal function and literature dosing recommendations&#xD;
CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h&#xD;
CrCL &lt; 30 mL/min: 6 - 10 mg/kg IV q48h&#xD;
Linezolid: 600 mg IV/PO q12h</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Vancomycin</title>
          <description>Vancomycin: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;&#xD;
Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;</description>
        </group>
        <group group_id="B2">
          <title>Comparator</title>
          <description>Ceftaroline: Dose based on package insert labeling&#xD;
CrCL &gt; 50 mL/min: 600 mg IV q12h&#xD;
CrCL 31-50 mL/min: 400 mg q12h&#xD;
CrCL 15-30 mL/min: 300 mg q12h&#xD;
CrCL &lt; 15mL/min: 200 mg q12h;&#xD;
Daptomycin: Dose based on renal function and literature dosing recommendations&#xD;
CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h&#xD;
CrCL &lt; 30 mL/min: 6 - 10 mg/kg IV q48h&#xD;
Linezolid: 600 mg IV/PO q12h</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="51"/>
            <count group_id="B2" value="49"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" lower_limit="51" upper_limit="68"/>
                    <measurement group_id="B2" value="60" lower_limit="51" upper_limit="68"/>
                    <measurement group_id="B3" value="60" lower_limit="53" upper_limit="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Individuals With Nephrotoxicity</title>
        <description>Increase in SCr of 0.5 mg/dL or 50% above baseline for at least two consecutive days while on the study drug and through discharge from hospital.&#xD;
This measure will be reported as proportion of patients with nephrotoxicity within each group in relation to the number of patients in each group.</description>
        <time_frame>Day 1 and daily serum creatinine assessment up to date of discharge from hospital, and a median of 7 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vancomycin</title>
            <description>Vancomycin: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;&#xD;
Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;</description>
          </group>
          <group group_id="O2">
            <title>Comparator</title>
            <description>Ceftaroline: Dose based on package insert labeling&#xD;
CrCL &gt; 50 mL/min: 600 mg IV q12h&#xD;
CrCL 31-50 mL/min: 400 mg q12h&#xD;
CrCL 15-30 mL/min: 300 mg q12h&#xD;
CrCL &lt; 15mL/min: 200 mg q12h;&#xD;
Daptomycin: Dose based on renal function and literature dosing recommendations&#xD;
CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h&#xD;
CrCL &lt; 30 mL/min: 6 - 10 mg/kg IV q48h&#xD;
Linezolid: 600 mg IV/PO q12h</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Individuals With Nephrotoxicity</title>
          <description>Increase in SCr of 0.5 mg/dL or 50% above baseline for at least two consecutive days while on the study drug and through discharge from hospital.&#xD;
This measure will be reported as proportion of patients with nephrotoxicity within each group in relation to the number of patients in each group.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Individuals With Acute Kidney Injury Network Modified Definition of Nephrotoxicity</title>
        <description>An abrupt (within 48 hour) reduction in kidney function with one or more of the following 1) Increase in SCr ≥ 0.3 mg/dL 2) Increase SCr ≥ 50% or 3) Decreased urine output (&lt; 0.5 ml/kg/hr x 6 hrs) while on the study drug.&#xD;
This measure will be reported as proportion of patients with acute kidney injury within each group in relation to the number of patients in each group.</description>
        <time_frame>Day 1 and daily serum creatinine assessment up to date of discharge, and a median of 7 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vancomycin</title>
            <description>Vancomycin: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;&#xD;
Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;</description>
          </group>
          <group group_id="O2">
            <title>Comparator</title>
            <description>Ceftaroline: Dose based on package insert labeling&#xD;
CrCL &gt; 50 mL/min: 600 mg IV q12h&#xD;
CrCL 31-50 mL/min: 400 mg q12h&#xD;
CrCL 15-30 mL/min: 300 mg q12h&#xD;
CrCL &lt; 15mL/min: 200 mg q12h;&#xD;
Daptomycin: Dose based on renal function and literature dosing recommendations&#xD;
CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h&#xD;
CrCL &lt; 30 mL/min: 6 - 10 mg/kg IV q48h&#xD;
Linezolid: 600 mg IV/PO q12h</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Individuals With Acute Kidney Injury Network Modified Definition of Nephrotoxicity</title>
          <description>An abrupt (within 48 hour) reduction in kidney function with one or more of the following 1) Increase in SCr ≥ 0.3 mg/dL 2) Increase SCr ≥ 50% or 3) Decreased urine output (&lt; 0.5 ml/kg/hr x 6 hrs) while on the study drug.&#xD;
This measure will be reported as proportion of patients with acute kidney injury within each group in relation to the number of patients in each group.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Individuals With Clinical Success</title>
        <description>Clinical success is a composite endpoint of those patients with clinical cure or improvement in clinical signs and symptoms of infection (i.e. SIRS criteria, and microbiology) while on the study drug.&#xD;
This measure will be reported as the proportion of patients with clinical success in each group compared to the the total number of patients in the group.</description>
        <time_frame>Daily assessment of signs and symptoms of infection, and a median of 7 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vancomycin</title>
            <description>Vancomycin: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;&#xD;
Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;</description>
          </group>
          <group group_id="O2">
            <title>Comparator</title>
            <description>Ceftaroline: Dose based on package insert labeling&#xD;
CrCL &gt; 50 mL/min: 600 mg IV q12h&#xD;
CrCL 31-50 mL/min: 400 mg q12h&#xD;
CrCL 15-30 mL/min: 300 mg q12h&#xD;
CrCL &lt; 15mL/min: 200 mg q12h;&#xD;
Daptomycin: Dose based on renal function and literature dosing recommendations&#xD;
CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h&#xD;
CrCL &lt; 30 mL/min: 6 - 10 mg/kg IV q48h&#xD;
Linezolid: 600 mg IV/PO q12h</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Individuals With Clinical Success</title>
          <description>Clinical success is a composite endpoint of those patients with clinical cure or improvement in clinical signs and symptoms of infection (i.e. SIRS criteria, and microbiology) while on the study drug.&#xD;
This measure will be reported as the proportion of patients with clinical success in each group compared to the the total number of patients in the group.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Clinical Success</title>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Clinical Failure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Vancomycin</title>
          <description>Vancomycin: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;&#xD;
Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;</description>
        </group>
        <group group_id="E2">
          <title>Comparator</title>
          <description>Ceftaroline: Dose based on package insert labeling&#xD;
CrCL &gt; 50 mL/min: 600 mg IV q12h&#xD;
CrCL 31-50 mL/min: 400 mg q12h&#xD;
CrCL 15-30 mL/min: 300 mg q12h&#xD;
CrCL &lt; 15mL/min: 200 mg q12h;&#xD;
Daptomycin: Dose based on renal function and literature dosing recommendations&#xD;
CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h&#xD;
CrCL &lt; 30 mL/min: 6 - 10 mg/kg IV q48h&#xD;
Linezolid: 600 mg IV/PO q12h</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrotoxicity</sub_title>
                <description>Increase in SCr of at least 0.5 mg/dL or 50% (whichever is greater) on at least 2 consecutive measurements while on the study drug.</description>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <description>An abrupt change in renal function signified by an increase in SCr of at least 0.3 mg/dL, a reduction in creatinine clearance (CrCl) of at least 50%, or a change in urine output to &lt;0.5 mL/kg/h for at least 6 hours.</description>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jose Vazquez</name_or_title>
      <organization>Augusta University</organization>
      <phone>(706) 723-0105</phone>
      <email>JVAZQUEZ@augusta.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01734694
org study id: 7089
nct id: NCT01734694
lead sponsor: 
For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of
      vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed
      and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical
      concern. This may be due to various reasons, including new dosing recommendations as well as
      an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity.
      This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin
      use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Proportion of Individuals With Nephrotoxicity
time frame: Day 1 and daily serum creatinine assessment up to date of discharge from hospital, and a median of 7 days.
description: Increase in SCr of 0.5 mg/dL or 50% above baseline for at least two consecutive days while on the study drug and through discharge from hospital.
This measure will be reported as proportion of patients with nephrotoxicity within each group in relation to the number of patients in each group.
measure: Proportion of Individuals With Acute Kidney Injury Network Modified Definition of Nephrotoxicity
time frame: Day 1 and daily serum creatinine assessment up to date of discharge, and a median of 7 days.
description: An abrupt (within 48 hour) reduction in kidney function with one or more of the following 1) Increase in SCr ≥ 0.3 mg/dL 2) Increase SCr ≥ 50% or 3) Decreased urine output (< 0.5 ml/kg/hr x 6 hrs) while on the study drug.
This measure will be reported as proportion of patients with acute kidney injury within each group in relation to the number of patients in each group.
measure: Proportion of Individuals With Clinical Success
time frame: Daily assessment of signs and symptoms of infection, and a median of 7 days.
description: Clinical success is a composite endpoint of those patients with clinical cure or improvement in clinical signs and symptoms of infection (i.e. SIRS criteria, and microbiology) while on the study drug.
This measure will be reported as the proportion of patients with clinical success in each group compared to the the total number of patients in the group.
arm group label: Vancomycin
arm group type: Active Comparator
arm group label: Comparator
arm group type: Active Comparator
intervention type: Drug
intervention name: Vancomycin
description: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;
Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;
arm group label: Vancomycin
intervention type: Drug
intervention name: Ceftaroline
description: Dose based on package insert labeling
CrCL > 50 mL/min: 600 mg IV q12h
CrCL 31-50 mL/min: 400 mg q12h
CrCL 15-30 mL/min: 300 mg q12h
CrCL < 15mL/min: 200 mg q12h;
arm group label: Comparator
other name: Teflaro
intervention type: Drug
intervention name: Daptomycin
description: Dose based on renal function and literature dosing recommendations
CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h
CrCL < 30 mL/min: 6 - 10 mg/kg IV q48h
arm group label: Comparator
other name: Cubicin
intervention type: Drug
intervention name: Linezolid
description: 600 mg IV/PO q12h
arm group label: Comparator
other name: Zyvox
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jose Vazquez, M.D.
role: Principal Investigator
affiliation: Henry Ford Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Jose Vazquez
investigator title: M.D.
mesh term: Bacteremia
mesh term: Osteomyelitis
mesh term: Arthritis, Infectious
mesh term: Healthcare-Associated Pneumonia
mesh term: Endocarditis
mesh term: Vancomycin
mesh term: Linezolid
mesh term: Daptomycin
mesh term: Ceftaroline fosamil
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 