<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/NCT02208063</url>
  </required_header>
  <id_info>
    <org_study_id>0112</org_study_id>
    <nct_id>NCT02208063</nct_id>
  </id_info>
  <brief_title>A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial</brief_title>
  <official_title>A Phase 3 Multicenter, Randomized, Open-label, Clinical Trial of Telavancin Versus Standard Intravenous Therapy in the Treatment of Subjects With Staphylococcus Aureus Bacteremia Including Infective Endocarditis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cumberland Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cumberland Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus&#xD;
      standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin&#xD;
      (PCN), or cefazolin) in the treatment of subjects with complicated Staphylococcus aureus (S.&#xD;
      aureus) bacteremia and SA right-sided infective endocarditis (SA-RIE).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Halted due to lack of statistical power. No safety concerns identified.&#xD;
  </why_stopped>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">April 12, 2018</completion_date>
  <primary_completion_date type="Actual">April 12, 2018</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>The efficacy endpoint of clinical outcome of cure at the test of cure (TOC) was determined by subjects who meet all of the following criteria, as determined by the investigator and adjudicated by the blinded independent efficacy adjudication committee (IEAC).&#xD;
Alive at TOC&#xD;
Resolution of all clinical signed and symptoms of the Staphylococcus aureus (S. aureus) infection at TOC&#xD;
No evidence of microbiological persistence of relapse&#xD;
No new foci of metastatic S. aureus infection after Day 8</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>The efficacy endpoint of Investigator clinical outcome of cure at the test of cure (TOC) was determined by the following criteria:&#xD;
Subject alive at TOC&#xD;
Resolution of all clinical signs and symptoms of the S. aureus infection at TOC (unless explained by a more likely alternative diagnosis)&#xD;
No evidence of microbiological persistence or relapse&#xD;
No new foci of metastatic S. aureus infection after Day 8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>This efficacy endpoint was determined to be a clinical failure if the subject switched study antibiotic due to lack of clinical response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations</measure>
    <time_frame>Day 8</time_frame>
    <description>After Day 8, any sign or symptom leading to a subsequent confirmed diagnosis of a new metastatic foci of S. aureus infection</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Bacteremia</condition>
  <arm_group>
    <arm_group_label>Telavancin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vancomycin, Daptomycin, synthetic penicillin or Cefazolin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telavancin</intervention_name>
    <arm_group_label>Telavancin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin</intervention_name>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daptomycin</intervention_name>
    <arm_group_label>Standard of care</arm_group_label>
    <other_name>Cubicin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Synthetic penicillin</intervention_name>
    <arm_group_label>Standard of care</arm_group_label>
    <other_name>Nafcillin</other_name>
    <other_name>Oxacillin</other_name>
    <other_name>Cloxacillin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefazolin</intervention_name>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older with at least one blood culture positive for S. aureus within&#xD;
             48 hours before randomization&#xD;
&#xD;
          -  At least one of the following signs or symptoms of bacteremia:&#xD;
&#xD;
               -  Temperature ≥ 38.0°C&#xD;
&#xD;
               -  White blood cell (WBC) count &gt; 10,000 or &lt; 4,000 cells/µL or &gt; 10% immature&#xD;
                  neutrophils (bands)&#xD;
&#xD;
               -  Tachycardia (heart rate &gt; 90 bpm)&#xD;
&#xD;
               -  Tachypnea (respiratory rate &gt; 20 breaths/min)&#xD;
&#xD;
               -  Hypotension (systolic blood pressure &lt; 90 mmHg)&#xD;
&#xD;
               -  Signs or symptoms of localized catheter-related infection&#xD;
&#xD;
          -  At enrollment, subjects must have either 1) known right-sided infective endocarditis&#xD;
             by Modified Duke's criteria 2) known complicated bacteremia, demonstrated as signs or&#xD;
             symptoms of metastatic foci of S. aureus infection or 3) at least one risk factor for&#xD;
             complicated bacteremia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for&#xD;
             more than 60 hours within 7 days before randomization. EXCEPTION: Documented&#xD;
             resistance to the prior systemic antibacterial therapy&#xD;
&#xD;
          -  Presence of an infection source that will not be managed or controlled within the&#xD;
             first 3 days of study drug treatment&#xD;
&#xD;
          -  Presence of prosthetic cardiac valve or cardiac device (eg, implantable cardioverter&#xD;
             defibrillator [ICD]), permanent pacemaker, or cardiac valve support ring)&#xD;
&#xD;
          -  Known or suspected left-sided infective endocarditis (LIE), by Modified Duke Criteria.&#xD;
             NOTE: Right-sided infective endocarditis (RIE) is permitted&#xD;
&#xD;
          -  Known or suspected osteomyelitis or meningitis. NOTE: Evidence of metastatic&#xD;
             complications related to the primary infection such as right-sided endocarditis,&#xD;
             septic arthritis, septic pulmonary emboli are permitted. S. aureus pneumonia is&#xD;
             permitted&#xD;
&#xD;
          -  Confirmed evidence (identification or gram stain) of a mixed polymicrobial infection&#xD;
             with a Gram-negative pathogen that requires non-study antibiotic treatment with&#xD;
             agent(s) that have activity against Gram-negative pathogens&#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>Medical Monitor</last_name>
    <role>Study Director</role>
    <affiliation>Cumberland Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Remington-Davis Clinical Research</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <results_first_submitted>October 16, 2019</results_first_submitted>
  <results_first_submitted_qc>February 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 17, 2020</results_first_posted>
  <last_update_submitted>February 13, 2020</last_update_submitted>
  <last_update_submitted_qc>February 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bacteremia</keyword>
  <keyword>Staphylococcus aureus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacteremia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vancomycin</mesh_term>
    <mesh_term>Cefazolin</mesh_term>
    <mesh_term>Daptomycin</mesh_term>
    <mesh_term>Penicillins</mesh_term>
    <mesh_term>Cloxacillin</mesh_term>
    <mesh_term>Oxacillin</mesh_term>
    <mesh_term>Nafcillin</mesh_term>
    <mesh_term>Telavancin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT02208063/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT02208063/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Telavancin</title>
          <description>7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes&#xD;
Telavancin</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>Vancomycin, Daptomycin, synthetic penicillin or Cefazolin&#xD;
Vancomycin&#xD;
Daptomycin&#xD;
Synthetic penicillin&#xD;
Cefazolin</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Randomized and Treated</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Microbiological All Treated</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not Specified in report</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Demographic (All-Treated Population)</population>
      <group_list>
        <group group_id="B1">
          <title>Telavancin</title>
          <description>7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes&#xD;
Telavancin</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>Vancomycin, Daptomycin, synthetic penicillin or Cefazolin&#xD;
Vancomycin&#xD;
Daptomycin&#xD;
Synthetic penicillin&#xD;
Cefazolin</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="57"/>
            <count group_id="B2" value="60"/>
            <count group_id="B3" value="117"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.3" spread="16.41"/>
                    <measurement group_id="B2" value="56.5" spread="16.33"/>
                    <measurement group_id="B3" value="54.5" spread="16.44"/>
                  </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="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiple</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)</title>
        <description>The efficacy endpoint of clinical outcome of cure at the test of cure (TOC) was determined by subjects who meet all of the following criteria, as determined by the investigator and adjudicated by the blinded independent efficacy adjudication committee (IEAC).&#xD;
Alive at TOC&#xD;
Resolution of all clinical signed and symptoms of the Staphylococcus aureus (S. aureus) infection at TOC&#xD;
No evidence of microbiological persistence of relapse&#xD;
No new foci of metastatic S. aureus infection after Day 8</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Telavancin</title>
            <description>7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes&#xD;
Telavancin</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Vancomycin, Daptomycin, synthetic penicillin or Cefazolin&#xD;
Vancomycin&#xD;
Daptomycin&#xD;
Synthetic penicillin&#xD;
Cefazolin</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)</title>
          <description>The efficacy endpoint of clinical outcome of cure at the test of cure (TOC) was determined by subjects who meet all of the following criteria, as determined by the investigator and adjudicated by the blinded independent efficacy adjudication committee (IEAC).&#xD;
Alive at TOC&#xD;
Resolution of all clinical signed and symptoms of the Staphylococcus aureus (S. aureus) infection at TOC&#xD;
No evidence of microbiological persistence of relapse&#xD;
No new foci of metastatic S. aureus infection after Day 8</description>
          <population>One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population</title>
        <description>The efficacy endpoint of Investigator clinical outcome of cure at the test of cure (TOC) was determined by the following criteria:&#xD;
Subject alive at TOC&#xD;
Resolution of all clinical signs and symptoms of the S. aureus infection at TOC (unless explained by a more likely alternative diagnosis)&#xD;
No evidence of microbiological persistence or relapse&#xD;
No new foci of metastatic S. aureus infection after Day 8</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Telavancin</title>
            <description>7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes&#xD;
Telavancin</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Vancomycin, Daptomycin, synthetic penicillin or Cefazolin&#xD;
Vancomycin&#xD;
Daptomycin&#xD;
Synthetic penicillin&#xD;
Cefazolin</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population</title>
          <description>The efficacy endpoint of Investigator clinical outcome of cure at the test of cure (TOC) was determined by the following criteria:&#xD;
Subject alive at TOC&#xD;
Resolution of all clinical signs and symptoms of the S. aureus infection at TOC (unless explained by a more likely alternative diagnosis)&#xD;
No evidence of microbiological persistence or relapse&#xD;
No new foci of metastatic S. aureus infection after Day 8</description>
          <population>One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population</title>
        <description>This efficacy endpoint was determined to be a clinical failure if the subject switched study antibiotic due to lack of clinical response</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Telavancin</title>
            <description>7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes&#xD;
Telavancin</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Vancomycin, Daptomycin, synthetic penicillin or Cefazolin&#xD;
Vancomycin&#xD;
Daptomycin&#xD;
Synthetic penicillin&#xD;
Cefazolin</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population</title>
          <description>This efficacy endpoint was determined to be a clinical failure if the subject switched study antibiotic due to lack of clinical response</description>
          <population>One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Success</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations</title>
        <description>After Day 8, any sign or symptom leading to a subsequent confirmed diagnosis of a new metastatic foci of S. aureus infection</description>
        <time_frame>Day 8</time_frame>
        <population>One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Telavancin</title>
            <description>7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes&#xD;
Telavancin</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Vancomycin, Daptomycin, synthetic penicillin or Cefazolin&#xD;
Vancomycin&#xD;
Daptomycin&#xD;
Synthetic penicillin&#xD;
Cefazolin</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations</title>
          <description>After Day 8, any sign or symptom leading to a subsequent confirmed diagnosis of a new metastatic foci of S. aureus infection</description>
          <population>One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>38 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Telavancin</title>
          <description>7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes&#xD;
Telavancin</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>Vancomycin, Daptomycin, synthetic penicillin or Cefazolin&#xD;
Vancomycin&#xD;
Daptomycin&#xD;
Synthetic penicillin&#xD;
Cefazolin</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA®; version 18</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Cardiovascular insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Multi-organ failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Unintentional medical device removal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Extradural abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Serratia infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Spinal empyema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Malignant peritoneal neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA®; version 18</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="58"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="58"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="58"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="58"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="60"/>
              </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>
    <limitations_and_caveats>At the interim analysis, study was deemed to be inadequately powered &amp; terminated prematurely.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Senior Director of Clinical and Regulatory Affairs</name_or_title>
      <organization>Cumberland Pharmaceuticals Inc.</organization>
      <phone>615-255-0068</phone>
      <email>ahaeberle@cumberlandpharma.com</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/NCT02208063
org study id: 0112
nct id: NCT02208063
lead sponsor: 
has dmc: Yes
This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus
      standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin
      (PCN), or cefazolin) in the treatment of subjects with complicated Staphylococcus aureus (S.
      aureus) bacteremia and SA right-sided infective endocarditis (SA-RIE).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)
time frame: Up to 8 weeks
description: The efficacy endpoint of clinical outcome of cure at the test of cure (TOC) was determined by subjects who meet all of the following criteria, as determined by the investigator and adjudicated by the blinded independent efficacy adjudication committee (IEAC).
Alive at TOC
Resolution of all clinical signed and symptoms of the Staphylococcus aureus (S. aureus) infection at TOC
No evidence of microbiological persistence of relapse
No new foci of metastatic S. aureus infection after Day 8
measure: Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population
time frame: Up to 8 weeks
description: The efficacy endpoint of Investigator clinical outcome of cure at the test of cure (TOC) was determined by the following criteria:
Subject alive at TOC
Resolution of all clinical signs and symptoms of the S. aureus infection at TOC (unless explained by a more likely alternative diagnosis)
No evidence of microbiological persistence or relapse
No new foci of metastatic S. aureus infection after Day 8
measure: Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population
time frame: Up to 8 weeks
description: This efficacy endpoint was determined to be a clinical failure if the subject switched study antibiotic due to lack of clinical response
measure: Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations
time frame: Day 8
description: After Day 8, any sign or symptom leading to a subsequent confirmed diagnosis of a new metastatic foci of S. aureus infection
arm group label: Telavancin
arm group type: Experimental
description: 7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes
arm group label: Standard of care
arm group type: Active Comparator
description: Vancomycin, Daptomycin, synthetic penicillin or Cefazolin
intervention type: Drug
intervention name: Telavancin
arm group label: Telavancin
intervention type: Drug
intervention name: Vancomycin
arm group label: Standard of care
intervention type: Drug
intervention name: Daptomycin
arm group label: Standard of care
other name: Cubicin
intervention type: Drug
intervention name: Synthetic penicillin
arm group label: Standard of care
other name: Nafcillin
other name: Oxacillin
other name: Cloxacillin
intervention type: Drug
intervention name: Cefazolin
arm group label: Standard of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Monitor
role: Study Director
affiliation: Cumberland Pharmaceuticals, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bacteremia
mesh term: Vancomycin
mesh term: Cefazolin
mesh term: Daptomycin
mesh term: Penicillins
mesh term: Cloxacillin
mesh term: Oxacillin
mesh term: Nafcillin
mesh term: Telavancin
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: At the interim analysis, study was deemed to be inadequately powered & terminated prematurely.
point of contact: 