<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/NCT03233438</url>
  </required_header>
  <id_info>
    <org_study_id>CMO-US-ID-0528</org_study_id>
    <nct_id>NCT03233438</nct_id>
  </id_info>
  <brief_title>Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)</brief_title>
  <official_title>Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effect of a new critical pathway (use of&#xD;
      guideline-based patient identification criteria and for those who meet these criteria, use of&#xD;
      dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin&#xD;
      Structure Infections)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Actual">October 30, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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 Infection-related Total Admitted Hospital Days</measure>
    <time_frame>44 Days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Total Admitted Hospital Days</measure>
    <time_frame>44 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time</measure>
    <time_frame>44 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Infection-related Hospitalizations</measure>
    <time_frame>44 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit</measure>
    <time_frame>44 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital</measure>
    <time_frame>Follow-up: 30 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Infection-related Emergency Department (ED) Visits</measure>
    <time_frame>44 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Infection-related Outpatient Healthcare Visits</measure>
    <time_frame>44 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy</measure>
    <time_frame>44 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy</measure>
    <time_frame>44 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Response to Treatment at End of Treatment Visit</measure>
    <time_frame>Baseline, Day 14</time_frame>
    <description>Response to treatment (healthcare provider assessment) comparing response at the Day 14 visit. Response to treatment will be defined through an assessment of erythema (measurement of lesion characteristics) and the absence of fever</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs)</measure>
    <time_frame>44 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Overall Health</measure>
    <time_frame>14 Days</time_frame>
    <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Wait in Emergency Room</measure>
    <time_frame>14 Days</time_frame>
    <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Hospitalization</measure>
    <time_frame>14 Days</time_frame>
    <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Satisfaction With Hospital Stay</measure>
    <time_frame>14 Days</time_frame>
    <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay</measure>
    <time_frame>14 Days</time_frame>
    <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections</measure>
    <time_frame>14 Days</time_frame>
    <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy</measure>
    <time_frame>14 Days</time_frame>
    <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV</measure>
    <time_frame>14 Days</time_frame>
    <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV</measure>
    <time_frame>14 Days</time_frame>
    <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living</measure>
    <time_frame>14 Days</time_frame>
    <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy</measure>
    <time_frame>14 Days</time_frame>
    <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day</measure>
    <time_frame>14 Days</time_frame>
    <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV</measure>
    <time_frame>14 Days</time_frame>
    <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV</measure>
    <time_frame>14 Days</time_frame>
    <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV</measure>
    <time_frame>14 Days</time_frame>
    <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Care: Find Value in a Physician</measure>
    <time_frame>14 Days</time_frame>
    <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire</measure>
    <time_frame>Day 10-14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire</measure>
    <time_frame>Day 14</time_frame>
    <description>The SF-12 yields a physical and a mental health component summary score (referred to as physical component summary score [PCS] and mental component summary score [MCS]). The PCS and MCS follow a t-score distribution, i.e. mean of 50 and standard deviation of 10 in the general US population, meaning all scores above or below 50 are above and below the average, respectively, in the US general population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Costs</measure>
    <time_frame>44 Days</time_frame>
    <description>Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Bacterial Infections</condition>
  <condition>Acute Bacterial Skin and Skin Structure Infection</condition>
  <arm_group>
    <arm_group_label>New Critical Pathway</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dalbavancin</intervention_name>
    <description>Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.</description>
    <arm_group_label>New Critical Pathway</arm_group_label>
    <other_name>Dalvance®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted patients who meets the clinical definition for Acute Bacterial Skin and Skin&#xD;
             Structure Infections (ABSSSI)&#xD;
&#xD;
          -  Known or suspected gram-positive infection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected gram-negative infections, anaerobic infections, or fungemia&#xD;
&#xD;
          -  Known or suspected infections that are severe, life threatening or are not included in&#xD;
             the ABSSSI Food and Drug Administration (FDA) guidance&#xD;
&#xD;
          -  Injection drug users with a fever&#xD;
&#xD;
          -  Severe neurological disorder leading to immobility or confined to a wheelchair&#xD;
&#xD;
          -  Bilateral Lower extremity involvement of the suspected infection.&#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>Patrick Gillard</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://AllerganClinicalTrials.com</url>
    <description>Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <results_first_submitted>October 30, 2019</results_first_submitted>
  <results_first_submitted_qc>January 7, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 18, 2020</results_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Critical Pathways</keyword>
  <keyword>Health Facilities</keyword>
  <keyword>Clinical Protocols</keyword>
  <keyword>Patient Satisfaction</keyword>
  <keyword>Absenteeism</keyword>
  <keyword>Anti-Bacterial Agents</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Economics, Medical</keyword>
  <keyword>Health Resources</keyword>
  <keyword>Health resource utilization</keyword>
  <keyword>Acute bacterial skin and skin structure infection (ABSSSI)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Bacterial Infections</mesh_term>
    <mesh_term>Skin Diseases, Bacterial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dalbavancin</mesh_term>
  </intervention_browse>
  <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>March 3, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03233438/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>May 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03233438/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Usual Care</title>
          <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
        </group>
        <group group_id="P2">
          <title>New Critical Pathway</title>
          <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No recording of dalbavancin</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
      <group_list>
        <group group_id="B1">
          <title>Usual Care</title>
          <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
        </group>
        <group group_id="B2">
          <title>New Critical Pathway</title>
          <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</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="48"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="90"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;20 years</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>
                  <title>20-29 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>30-39 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>40-49 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>50-59 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>60-69 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>70-79 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>80-89 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>90-98 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </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="24"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="46"/>
                  </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="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="11"/>
                  </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>
              <category_list>
                <category>
                  <title>White or Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</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>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</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>
                  <title>Patient chose not to answer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Infection-related Total Admitted Hospital Days</title>
        <time_frame>44 Days</time_frame>
        <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Infection-related Total Admitted Hospital Days</title>
          <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="2.55"/>
                    <measurement group_id="O2" value="3.2" spread="2.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.6</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.5</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.6</ci_lower_limit>
            <ci_upper_limit>2.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Total Admitted Hospital Days</title>
        <time_frame>44 Days</time_frame>
        <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Total Admitted Hospital Days</title>
          <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="2.62"/>
                    <measurement group_id="O2" value="3.2" spread="2.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.7</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.56</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.6</ci_lower_limit>
            <ci_upper_limit>2.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time</title>
        <time_frame>44 Days</time_frame>
        <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time</title>
          <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</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="48"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No Surgeries</title>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Expected Surgeries</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <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 Infection-related Hospitalizations</title>
        <time_frame>44 Days</time_frame>
        <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Infection-related Hospitalizations</title>
          <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</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="48"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1 Occurrence</title>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 Occurrences</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit</title>
        <time_frame>44 Days</time_frame>
        <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit</title>
          <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</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="48"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Admission to ICU</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital</title>
        <time_frame>Follow-up: 30 Days</time_frame>
        <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital</title>
          <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</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="48"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 Occurrence</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Infection-related Emergency Department (ED) Visits</title>
        <time_frame>44 Days</time_frame>
        <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Infection-related Emergency Department (ED) Visits</title>
          <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</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="48"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 Occurrence</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Infection-related Outpatient Healthcare Visits</title>
        <time_frame>44 Days</time_frame>
        <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Infection-related Outpatient Healthcare Visits</title>
          <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</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="48"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Any</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy</title>
        <time_frame>44 Days</time_frame>
        <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy</title>
          <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</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="48"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Central Line</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PICC Line</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Peripheral IV</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Line</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy</title>
        <time_frame>44 Days</time_frame>
        <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy</title>
          <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</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="48"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 Occurrence</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Response to Treatment at End of Treatment Visit</title>
        <description>Response to treatment (healthcare provider assessment) comparing response at the Day 14 visit. Response to treatment will be defined through an assessment of erythema (measurement of lesion characteristics) and the absence of fever</description>
        <time_frame>Baseline, Day 14</time_frame>
        <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Response to Treatment at End of Treatment Visit</title>
          <description>Response to treatment (healthcare provider assessment) comparing response at the Day 14 visit. Response to treatment will be defined through an assessment of erythema (measurement of lesion characteristics) and the absence of fever</description>
          <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</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="48"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Complete response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Partial response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Failure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs)</title>
        <time_frame>44 Days</time_frame>
        <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs)</title>
          <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</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="48"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: Overall Health</title>
        <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
        <time_frame>14 Days</time_frame>
        <population>FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Overall Health</title>
          <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
          <population>FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.</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="43"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Excellent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fair</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Poor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: Wait in Emergency Room</title>
        <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
        <time_frame>14 Days</time_frame>
        <population>FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Wait in Emergency Room</title>
          <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
          <population>FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="3.34"/>
                    <measurement group_id="O2" value="6.9" spread="3.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: Hospitalization</title>
        <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
        <time_frame>14 Days</time_frame>
        <population>FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Hospitalization</title>
          <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
          <population>FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.</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="43"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: Satisfaction With Hospital Stay</title>
        <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
        <time_frame>14 Days</time_frame>
        <population>FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Satisfaction With Hospital Stay</title>
          <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
          <population>FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" spread="2.35"/>
                    <measurement group_id="O2" value="7.4" spread="2.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay</title>
        <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
        <time_frame>14 Days</time_frame>
        <population>43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all questions in the usual care group &amp; new critical pathway group; 42 &amp; 34 patients answered this question in the usual care group &amp; new critical pathway group, respectively. Patients may have checked multiple responses.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay</title>
          <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
          <population>43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all questions in the usual care group &amp; new critical pathway group; 42 &amp; 34 patients answered this question in the usual care group &amp; new critical pathway group, respectively. Patients may have checked multiple responses.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hospital stay interfered with work/school</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stay got in way of daily normal activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stay got in the way of providing care to others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hospital stay was expensive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did not provide adequate monitoring by providers</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did not provide well trained healthcare providers</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hospital stay made me feel worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hospital stay made me feel concerned</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hospital stay was uncomfortable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hospital stay disrupted my sleep</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I was not dissatisfied with my hospital stay</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections</title>
        <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
        <time_frame>14 Days</time_frame>
        <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 43 &amp; 33 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections</title>
          <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
          <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 43 &amp; 33 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</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="43"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy</title>
        <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
        <time_frame>14 Days</time_frame>
        <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 43 &amp; 33 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy</title>
          <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
          <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 43 &amp; 33 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="2.83"/>
                    <measurement group_id="O2" value="8.1" spread="2.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV</title>
        <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
        <time_frame>14 Days</time_frame>
        <population>43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all questions in the usual care group &amp; new critical pathway group; 43 &amp; 33 patients answered this question in the usual care group &amp; new critical pathway group, respectively. Patients may have checked multiple responses.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV</title>
          <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
          <population>43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all questions in the usual care group &amp; new critical pathway group; 43 &amp; 33 patients answered this question in the usual care group &amp; new critical pathway group, respectively. Patients may have checked multiple responses.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Allowed me to return to work/school</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Allowed me to return to daily normal activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Allowed me to return to providing care to others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IV antibiotic therapy was affordable</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>
              <title>Administered at appointments that I could schedule</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Administered quickly once arrived at appt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Administered at setting that had convenient hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ensured regular monitoring by healthcare providers</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Administered by skilled healthcare providers</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IV antibiotic therapy made me feel better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Allowed to receive care for skin infection at home</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Convenient to administer by self/caregiver at home</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not satisfied with receiving IV antibiotic therapy</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>Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV</title>
        <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
        <time_frame>14 Days</time_frame>
        <population>43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all questions in the usual care group &amp; new critical pathway group; 43 &amp; 33 patients answered this question in the usual care group &amp; new critical pathway group, respectively. Patients may have checked multiple responses.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV</title>
          <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
          <population>43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all questions in the usual care group &amp; new critical pathway group; 43 &amp; 33 patients answered this question in the usual care group &amp; new critical pathway group, respectively. Patients may have checked multiple responses.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Got in the way of work/school</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Got in way of performing daily normal activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Got in the way of providing care to others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IV antibiotic therapy was expensive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Required me to make appointments</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Administered at healthcare setting w/limited hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Required traveling to and from appointments</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Required to wait to be seen by provider</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IV antibiotic therapy took too long to administer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Administered too frequently</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Required having a PICC or central line inserted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caused an IV site infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IV antibiotic therapy made me feel worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not adequately monitored by healthcare providers</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>Not administered by skilled healthcare providers</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IV antibiotic therapy made me feel concerned</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Required a nurse/healthcare worker coming to home</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Required administration to self/caregiver at home</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not dissatisfied w/receiving IV antibiotic therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living</title>
        <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
        <time_frame>14 Days</time_frame>
        <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 42 &amp; 33 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living</title>
          <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
          <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 42 &amp; 33 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</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="42"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>None of the time</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>A little of the time</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some of the time</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Most of the time</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>All of the time</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy</title>
        <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
        <time_frame>14 Days</time_frame>
        <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 42 &amp; 33 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy</title>
          <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
          <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 42 &amp; 33 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</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="42"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>None of the time</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>A little of the time</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some of the time</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Most of the time</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>All of the time</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day</title>
        <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
        <time_frame>14 Days</time_frame>
        <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 43 &amp; 33 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day</title>
          <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
          <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 43 &amp; 33 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="2.63"/>
                    <measurement group_id="O2" value="8.7" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV</title>
        <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
        <time_frame>14 Days</time_frame>
        <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 43 &amp; 33 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV</title>
          <description>Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.</description>
          <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 43 &amp; 33 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" spread="2.58"/>
                    <measurement group_id="O2" value="8.9" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV</title>
        <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
        <time_frame>14 Days</time_frame>
        <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 43 &amp; 34 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV</title>
          <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
          <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 43 &amp; 34 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</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="43"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Regimen 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Regimen 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Regimen 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV</title>
        <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
        <time_frame>14 Days</time_frame>
        <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 41 &amp; 34 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV</title>
          <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
          <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 41 &amp; 34 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</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="41"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>About 30 minutes or less</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>About 1 hour</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>About 1.5 to 2 hours</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>About 3 hours or longer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Care: Find Value in a Physician</title>
        <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
        <time_frame>14 Days</time_frame>
        <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 43 &amp; 34 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Find Value in a Physician</title>
          <description>Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).</description>
          <population>FAS Population. 43 &amp; 34 patients provided any survey data in the usual care group &amp; new critical pathway group; 40 &amp; 32 patients completed all survey questions in the usual care group &amp; new critical pathway group; 43 &amp; 34 patients answered this survey question in the usual care group &amp; new critical pathway group, respectively.</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="43"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Definitely not</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Probably not</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Probably so</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Definitely so</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire</title>
        <time_frame>Day 10-14</time_frame>
        <population>FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively.14 and 9 patients completed all survey questions in the usual care group and new critical pathway group, respectively. 17 and 20 patients were employed.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire</title>
          <population>FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively.14 and 9 patients completed all survey questions in the usual care group and new critical pathway group, respectively. 17 and 20 patients were employed.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Absenteeism</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.9" spread="38.49"/>
                    <measurement group_id="O2" value="36.7" spread="46.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Impairment while working</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.9" spread="40.03"/>
                    <measurement group_id="O2" value="8.9" spread="9.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall work impairment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.3" spread="39.16"/>
                    <measurement group_id="O2" value="18.0" spread="23.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity impairment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.2" spread="38.85"/>
                    <measurement group_id="O2" value="18.5" spread="26.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire</title>
        <description>The SF-12 yields a physical and a mental health component summary score (referred to as physical component summary score [PCS] and mental component summary score [MCS]). The PCS and MCS follow a t-score distribution, i.e. mean of 50 and standard deviation of 10 in the general US population, meaning all scores above or below 50 are above and below the average, respectively, in the US general population.</description>
        <time_frame>Day 14</time_frame>
        <population>FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 42 and 34 patients completed all survey questions in the usual care group and new critical pathway group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire</title>
          <description>The SF-12 yields a physical and a mental health component summary score (referred to as physical component summary score [PCS] and mental component summary score [MCS]). The PCS and MCS follow a t-score distribution, i.e. mean of 50 and standard deviation of 10 in the general US population, meaning all scores above or below 50 are above and below the average, respectively, in the US general population.</description>
          <population>FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 42 and 34 patients completed all survey questions in the usual care group and new critical pathway group, respectively.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mental Health Component Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.9" spread="10.28"/>
                    <measurement group_id="O2" value="50.8" spread="10.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Health Component Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.5" spread="11.37"/>
                    <measurement group_id="O2" value="46.3" spread="11.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healthcare Costs</title>
        <description>Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests</description>
        <time_frame>44 Days</time_frame>
        <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
          </group>
          <group group_id="O2">
            <title>New Critical Pathway</title>
            <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
          </group>
        </group_list>
        <measure>
          <title>Healthcare Costs</title>
          <description>Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests</description>
          <population>Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.</population>
          <units>USD</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13772.9" spread="7166.95"/>
                    <measurement group_id="O2" value="9421.6" spread="7122.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Usual Care</title>
          <description>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.</description>
        </group>
        <group group_id="E2">
          <title>New Critical Pathway</title>
          <description>The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MEDRA 20.0</default_vocab>
        <default_assessment>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="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MEDRA 20.0</default_vocab>
        <default_assessment>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="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="42"/>
              </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>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area, Head</name_or_title>
      <organization>Allergan</organization>
      <phone>714-246-4500</phone>
      <email>IR-CTRegistration@allergan.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/NCT03233438
org study id: CMO-US-ID-0528
nct id: NCT03233438
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the effect of a new critical pathway (use of
      guideline-based patient identification criteria and for those who meet these criteria, use of
      dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin
      Structure Infections)
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Infection-related Total Admitted Hospital Days
time frame: 44 Days
measure: Number of Total Admitted Hospital Days
time frame: 44 Days
measure: Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
time frame: 44 Days
measure: Number of Participants With Infection-related Hospitalizations
time frame: 44 Days
measure: Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit
time frame: 44 Days
measure: Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital
time frame: Follow-up: 30 Days
measure: Number of Participants With Infection-related Emergency Department (ED) Visits
time frame: 44 Days
measure: Number of Participants With Infection-related Outpatient Healthcare Visits
time frame: 44 Days
measure: Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
time frame: 44 Days
measure: Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy
time frame: 44 Days
measure: Change From Baseline in Response to Treatment at End of Treatment Visit
time frame: Baseline, Day 14
description: Response to treatment (healthcare provider assessment) comparing response at the Day 14 visit. Response to treatment will be defined through an assessment of erythema (measurement of lesion characteristics) and the absence of fever
measure: Number of Participants With Serious Adverse Events (SAEs)
time frame: 44 Days
measure: Patient Satisfaction With Care: Overall Health
time frame: 14 Days
description: Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
measure: Patient Satisfaction With Care: Wait in Emergency Room
time frame: 14 Days
description: Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
measure: Patient Satisfaction With Care: Hospitalization
time frame: 14 Days
description: Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
measure: Patient Satisfaction With Care: Satisfaction With Hospital Stay
time frame: 14 Days
description: Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
measure: Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
time frame: 14 Days
description: Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
measure: Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections
time frame: 14 Days
description: Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
measure: Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy
time frame: 14 Days
description: Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
measure: Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
time frame: 14 Days
description: Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
measure: Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
time frame: 14 Days
description: Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
measure: Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living
time frame: 14 Days
description: Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
measure: Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
time frame: 14 Days
description: Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
measure: Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day
time frame: 14 Days
description: Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
measure: Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV
time frame: 14 Days
description: Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
measure: Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV
time frame: 14 Days
description: Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
measure: Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV
time frame: 14 Days
description: Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
measure: Patient Satisfaction With Care: Find Value in a Physician
time frame: 14 Days
description: Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
measure: Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
time frame: Day 10-14
measure: Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire
time frame: Day 14
description: The SF-12 yields a physical and a mental health component summary score (referred to as physical component summary score [PCS] and mental component summary score [MCS]). The PCS and MCS follow a t-score distribution, i.e. mean of 50 and standard deviation of 10 in the general US population, meaning all scores above or below 50 are above and below the average, respectively, in the US general population.
measure: Healthcare Costs
time frame: 44 Days
description: Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests
arm group label: New Critical Pathway
arm group type: Active Comparator
description: The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
arm group label: Usual Care
arm group type: Active Comparator
description: Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
intervention type: Drug
intervention name: Dalbavancin
description: Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
arm group label: New Critical Pathway
other name: Dalvance®
intervention type: Drug
intervention name: Usual Care
description: Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick Gillard
role: Study Director
affiliation: Allergan
facility: 
country: United States
url: http://AllerganClinicalTrials.com
description: Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Bacterial Infections
mesh term: Skin Diseases, Bacterial
mesh term: Dalbavancin
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 