<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/NCT02991131</url>
  </required_header>
  <id_info>
    <org_study_id>18299</org_study_id>
    <secondary_id>SX1601</secondary_id>
    <nct_id>NCT02991131</nct_id>
  </id_info>
  <brief_title>Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study</brief_title>
  <acronym>DART</acronym>
  <official_title>DART: &quot;Sivextro® in Acute Bacterial Skin anD Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global ObseRvational STudy.&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This open-label, prospective, multi-center, non-interventional, observational, parallel&#xD;
      cohort study intended to provide real life data on the treatment duration, effectiveness and&#xD;
      safety of tedizolid and linezolid when treating ABSSSI hospitalized patients in a real&#xD;
      practice setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study was to assess the treatment duration in the real life in&#xD;
      2 cohorts consisting of patients treated by 200 mg once daily IV/PO tedizolid or treated by&#xD;
      600 mg twice daily IV/PO (intravenous/per oral) linezolid.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Company decision&#xD;
  </why_stopped>
  <start_date type="Actual">December 17, 2016</start_date>
  <completion_date type="Actual">November 21, 2018</completion_date>
  <primary_completion_date type="Actual">November 21, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of treatment days</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Duration of treatment is defined as the time interval from date of first administration of tedizolid or linezolid to the date of permanent discontinuation of tedizolid or linezolid, respectively.&#xD;
The treatment is according to the recommendations written in the local product information.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events or safety-relevant changes in laboratory parameters</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participants with investigator-assessed clinical response</measure>
    <time_frame>Up to 1 month</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">108</enrollment>
  <condition>Skin Disease, Infectious</condition>
  <arm_group>
    <arm_group_label>Tedizolid</arm_group_label>
    <description>Hospitalized ABSSSI patients treated with tedizolid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Linezolid</arm_group_label>
    <description>Hospitalized ABSSSI patients treated with linezolid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tedizolid (Sivextro, BAY1192631)</intervention_name>
    <description>Antibiotic</description>
    <arm_group_label>Tedizolid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Linezolid</intervention_name>
    <description>Antibiotic</description>
    <arm_group_label>Linezolid</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult female and male in-patients with clinical diagnosis compatible with ABSSSI&#xD;
             (cellulitis/erysipelas, major skin abscess or wound infections) with a clinical&#xD;
             suspicion of infection by Gram positive bacteria (with or without laboratory&#xD;
             confirmation).&#xD;
&#xD;
          -  Patients for whom the decision to initiate treatment with tedizolid phosphate or&#xD;
             linezolid was made as per physician's routine treatment practice.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients participating in an investigational program with interventions outside of&#xD;
             routine clinical practice.&#xD;
&#xD;
          -  Patients who have been enrolled in this study before.&#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>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
    <country>Colombia</country>
    <country>Philippines</country>
    <country>Saudi Arabia</country>
    <country>United Arab Emirates</country>
  </removed_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>September 30, 2019</last_update_submitted>
  <last_update_submitted_qc>September 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute bacterial skin infection</keyword>
  <keyword>Acute Bacterial Skin and Skin Structure Infection (ABSSSI)</keyword>
  <keyword>Abscess</keyword>
  <keyword>Cellulitis</keyword>
  <keyword>Erysipelas</keyword>
  <keyword>Wound infection</keyword>
  <keyword>Methicillin resistant Staphylococcus aureus (MRSA)</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>Skin Diseases, Bacterial</mesh_term>
    <mesh_term>Skin Diseases, Infectious</mesh_term>
    <mesh_term>Skin Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Linezolid</mesh_term>
    <mesh_term>Tedizolid</mesh_term>
    <mesh_term>Tedizolid phosphate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02991131
org study id: 18299
secondary id: SX1601
nct id: NCT02991131
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This open-label, prospective, multi-center, non-interventional, observational, parallel
      cohort study intended to provide real life data on the treatment duration, effectiveness and
      safety of tedizolid and linezolid when treating ABSSSI hospitalized patients in a real
      practice setting.
The primary objective of this study was to assess the treatment duration in the real life in
      2 cohorts consisting of patients treated by 200 mg once daily IV/PO tedizolid or treated by
      600 mg twice daily IV/PO (intravenous/per oral) linezolid.
observational model: Cohort
time perspective: Prospective
measure: Number of treatment days
time frame: Up to 1 month
description: Duration of treatment is defined as the time interval from date of first administration of tedizolid or linezolid to the date of permanent discontinuation of tedizolid or linezolid, respectively.
The treatment is according to the recommendations written in the local product information.
measure: Number of participants with adverse events or safety-relevant changes in laboratory parameters
time frame: Up to 1 month
measure: Number of participants with investigator-assessed clinical response
time frame: Up to 1 month
arm group label: Tedizolid
description: Hospitalized ABSSSI patients treated with tedizolid
arm group label: Linezolid
description: Hospitalized ABSSSI patients treated with linezolid
intervention type: Drug
intervention name: Tedizolid (Sivextro, BAY1192631)
description: Antibiotic
arm group label: Tedizolid
intervention type: Drug
intervention name: Linezolid
description: Antibiotic
arm group label: Linezolid
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
facility: 
facility: 
country: Mexico
country: Russian Federation
country: Singapore
country: Brazil
country: Colombia
country: Philippines
country: Saudi Arabia
country: United Arab Emirates
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Skin Diseases, Bacterial
mesh term: Skin Diseases, Infectious
mesh term: Skin Diseases
mesh term: Linezolid
mesh term: Tedizolid
mesh term: Tedizolid phosphate