<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/NCT04485676</url>
  </required_header>
  <id_info>
    <org_study_id>ANG-DAL-2019-01</org_study_id>
    <nct_id>NCT04485676</nct_id>
  </id_info>
  <brief_title>Dalbavancin in Real Clinical Practice in Spain</brief_title>
  <acronym>REAL-DAL</acronym>
  <official_title>Dalbavancin in Real Clinical Practice in Spain: a Two-year Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Angelini Farmacéutica</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Effice Servicios Para la Investigacion S.L.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Angelini Farmacéutica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to describe the real clinical use of Dalbavancin in Spain between&#xD;
      January 2018 and December 2019.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dalbavancin is a new lipoglycopeptide approved for the treatment of ABSSSIs (Acute Bacterial&#xD;
      Skin and Skin-Structure Infections) with activity against Gram-positive pathogens, including&#xD;
      MRSA. Dalbavancin has unique pharmacokinetics properties, with a terminal half-life of 14.4&#xD;
      days, permitting a single intravenous dosing. Dalbavancin has shown a favourable efficacy and&#xD;
      safety profile in patients with ABSSSI in randomized controlled trials. However, information&#xD;
      regarding daily clinical practice is limited. The main objective of this study is to describe&#xD;
      the real clinical practice with Dalbavancin in Spain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">February 21, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Demographic and clinical characteristics of patients treated with dalbavancin</measure>
    <time_frame>patients treated with dalbavancin between January 2018 and December 2019</time_frame>
    <description>To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variables related to dalbavancin treatment</measure>
    <time_frame>patients treated with dalbavancin between January 2018 and December 2019</time_frame>
    <description>To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness/Clinical response</measure>
    <time_frame>From 48-72h after the end of treatment until 90 days after last dose of dalbavancin</time_frame>
    <description>Clinical response (signs and symptoms) evaluated at the end of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness/Relapse</measure>
    <time_frame>90 days after after last dose of dalbavancin</time_frame>
    <description>Relapse (Yes/No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety. Adverse events</measure>
    <time_frame>From first dose until 90 days after last dose of dalbavancin</time_frame>
    <description>Rate of adverse events Rate of treatment discontinuation due to Adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment compliance</measure>
    <time_frame>: From first dose until 90 days after last dose of dalbavancin</time_frame>
    <description>Patient received the full dose of dalbavancin (Yes/No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Doctors opinion on infection management with dalbavancin (1)</measure>
    <time_frame>From first dose until 90 days after last dose of dalbavancin</time_frame>
    <description>Degree of physician satisfaction on management with dalbavancin: Dissatisfied, Little satisfied, Satisfied, Very satisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Doctors opinion on infection management with dalbavancin (2)</measure>
    <time_frame>From first dose until 90 days after last dose of dalbavancin</time_frame>
    <description>Physician assessment on potential reduction in the number of days of hospital stay (Yes/No)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">187</enrollment>
  <condition>Skin Diseases, Bacterial</condition>
  <condition>Skin Diseases, Infectious</condition>
  <arm_group>
    <arm_group_label>Dalbavancin</arm_group_label>
    <description>Patients to be included in this study have been treated with Dalbavancin according to clinician's judgement and clinical practice according national or international guidelines.&#xD;
Dalbavancin is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Information about dosing treatment will be collected.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with dalbavancin from 1st January 2018 to 31st December 2019&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult man and woman (≥ 18 years) at the time of receiving dalbavancin&#xD;
&#xD;
          2. Patients receiving at least one dose of dalbavancin between 1st January 2018 and 31st&#xD;
             December 2019&#xD;
&#xD;
          3. Patients with medical follow-up information registered in clinical records for about&#xD;
             90 days after completing the treatment&#xD;
&#xD;
          4. Written informed consent requested according to local regulation, IEC and protocol&#xD;
             requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Patient enrolled in a clinical trial in which treatment with dalbavancin is managed&#xD;
        through a protocol&#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>Benito Almirante, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Vall d'Hebrón</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario A Coruña</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebrón</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de las Nieves</name>
      <address>
        <city>Granada</city>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universtario La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 21, 2022</last_update_submitted>
  <last_update_submitted_qc>July 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Skin Diseases, Infectious</mesh_term>
    <mesh_term>Skin Diseases, Bacterial</mesh_term>
    <mesh_term>Skin Diseases</mesh_term>
  </condition_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/NCT04485676
org study id: ANG-DAL-2019-01
nct id: NCT04485676
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to describe the real clinical use of Dalbavancin in Spain between
      January 2018 and December 2019.
Dalbavancin is a new lipoglycopeptide approved for the treatment of ABSSSIs (Acute Bacterial
      Skin and Skin-Structure Infections) with activity against Gram-positive pathogens, including
      MRSA. Dalbavancin has unique pharmacokinetics properties, with a terminal half-life of 14.4
      days, permitting a single intravenous dosing. Dalbavancin has shown a favourable efficacy and
      safety profile in patients with ABSSSI in randomized controlled trials. However, information
      regarding daily clinical practice is limited. The main objective of this study is to describe
      the real clinical practice with Dalbavancin in Spain.
observational model: Other
time perspective: Retrospective
measure: Demographic and clinical characteristics of patients treated with dalbavancin
time frame: patients treated with dalbavancin between January 2018 and December 2019
description: To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective)
measure: Variables related to dalbavancin treatment
time frame: patients treated with dalbavancin between January 2018 and December 2019
description: To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective)
measure: Effectiveness/Clinical response
time frame: From 48-72h after the end of treatment until 90 days after last dose of dalbavancin
description: Clinical response (signs and symptoms) evaluated at the end of treatment
measure: Effectiveness/Relapse
time frame: 90 days after after last dose of dalbavancin
description: Relapse (Yes/No)
measure: Safety. Adverse events
time frame: From first dose until 90 days after last dose of dalbavancin
description: Rate of adverse events Rate of treatment discontinuation due to Adverse events
measure: Treatment compliance
time frame: : From first dose until 90 days after last dose of dalbavancin
description: Patient received the full dose of dalbavancin (Yes/No)
measure: Doctors opinion on infection management with dalbavancin (1)
time frame: From first dose until 90 days after last dose of dalbavancin
description: Degree of physician satisfaction on management with dalbavancin: Dissatisfied, Little satisfied, Satisfied, Very satisfied
measure: Doctors opinion on infection management with dalbavancin (2)
time frame: From first dose until 90 days after last dose of dalbavancin
description: Physician assessment on potential reduction in the number of days of hospital stay (Yes/No)
arm group label: Dalbavancin
description: Patients to be included in this study have been treated with Dalbavancin according to clinician's judgement and clinical practice according national or international guidelines.
Dalbavancin is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Information about dosing treatment will be collected.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benito Almirante, PhD
role: Principal Investigator
affiliation: Hospital Vall d'Hebrón
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Skin Diseases, Infectious
mesh term: Skin Diseases, Bacterial
mesh term: Skin Diseases