<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/NCT04413396</url>
  </required_header>
  <id_info>
    <org_study_id>OPATReg</org_study_id>
    <nct_id>NCT04413396</nct_id>
  </id_info>
  <brief_title>German Register of Outpatient Parenteral Antibiotic Therapy</brief_title>
  <acronym>OPATReg</acronym>
  <official_title>German Register of Outpatient Parenteral Antibiotic Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cologne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cologne</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>
      Many infectious diseases require a therapy that is administered intravenously due to a lack&#xD;
      of oral treatments. Affected patients often have to stay weeks or even months in hospital&#xD;
      just for receiving their therapy although they do not feel severely unwell.&#xD;
&#xD;
      Outpatient parenteral antibiotic therapy (OPAT) allows these patients under certain&#xD;
      requirements to get discharged from hospital and apply the antibiotic treatment on their own.&#xD;
      For these patients quality of life improves by feeling more comfortable at home and being&#xD;
      able to participate in everyday life or even go back to work. For the hospitals a reduced&#xD;
      inpatient health care means a clear reduction of costs.&#xD;
&#xD;
      The aim of OPATReg is to examine under which conditions the OPAT can be established at&#xD;
      different locations of patient care. For this purpose, patients with APAT are to be treated&#xD;
      and data collected at 7 university institutions in Germany. All centers have the expertise to&#xD;
      provide comprehensive care for patients with infectious diseases, to transfer them from&#xD;
      inpatient to outpatient care and to continue to provide care there.&#xD;
&#xD;
      If successful, the project should help to identify the potential of OPAT for all of Germany.&#xD;
      If positive effects and feasibility can be demonstrated OPAT could become an important&#xD;
      therapy option with many advantages for certain patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Weeks</target_duration>
  <primary_outcome>
    <measure>Number of Patients with effective OPAT</measure>
    <time_frame>12 weeks</time_frame>
    <description>Successful administration and completion of the antiinfective therapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients With Treatment-Related Adverse Events</measure>
    <time_frame>12 weeks</time_frame>
    <description>side-effects of treatment and catheter-related infections</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Hospitals being able to apply OPAT</measure>
    <time_frame>12 weeks</time_frame>
    <description>Feasibility of OPAT under differing hospital specific circumstances</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Implementation of OPAT in Germany</condition>
  <arm_group>
    <arm_group_label>Outpatient parenteral antimicrobial therapy</arm_group_label>
    <description>Patients with an infectious disease that receive an outpatient parenteral antimicrobial therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Outpatient Parenteral Antibiotic Therapy</intervention_name>
    <description>Application of outpatient parenteral antibiotic therapy in patients with infectious diseases to allow them to get discharged from hospital.</description>
    <arm_group_label>Outpatient parenteral antimicrobial therapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults getting OPAT in one of the participating study sites&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who get OPAT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who don't get OPAT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Clara Lehmann, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Head of Outpatient Department in ID, University Hospital of Cologne</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Clara Lehmann, Prof.</last_name>
    <phone>+4922147839684</phone>
    <email>clara.lehmann@uk-koeln.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Charlotte Leisse</last_name>
    <phone>+4922147842895</phone>
    <email>charlotte.leisse@uk-koeln.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital of Cologne</name>
      <address>
        <city>Cologne</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clara Lehmann, Prof.</last_name>
      <email>clara.lehmann@uk-koeln.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cologne</investigator_affiliation>
    <investigator_full_name>Clara Lehmann</investigator_full_name>
    <investigator_title>Head of outpatient clinic</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04413396
org study id: OPATReg
nct id: NCT04413396
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Many infectious diseases require a therapy that is administered intravenously due to a lack
      of oral treatments. Affected patients often have to stay weeks or even months in hospital
      just for receiving their therapy although they do not feel severely unwell.

      Outpatient parenteral antibiotic therapy (OPAT) allows these patients under certain
      requirements to get discharged from hospital and apply the antibiotic treatment on their own.
      For these patients quality of life improves by feeling more comfortable at home and being
      able to participate in everyday life or even go back to work. For the hospitals a reduced
      inpatient health care means a clear reduction of costs.

      The aim of OPATReg is to examine under which conditions the OPAT can be established at
      different locations of patient care. For this purpose, patients with APAT are to be treated
      and data collected at 7 university institutions in Germany. All centers have the expertise to
      provide comprehensive care for patients with infectious diseases, to transfer them from
      inpatient to outpatient care and to continue to provide care there.

      If successful, the project should help to identify the potential of OPAT for all of Germany.
      If positive effects and feasibility can be demonstrated OPAT could become an important
      therapy option with many advantages for certain patients.
observational model: Case-Only
time perspective: Prospective
measure: Number of Patients with effective OPAT
time frame: 12 weeks
description: Successful administration and completion of the antiinfective therapy
measure: Number of Patients With Treatment-Related Adverse Events
time frame: 12 weeks
description: side-effects of treatment and catheter-related infections
measure: Number of Hospitals being able to apply OPAT
time frame: 12 weeks
description: Feasibility of OPAT under differing hospital specific circumstances
arm group label: Outpatient parenteral antimicrobial therapy
description: Patients with an infectious disease that receive an outpatient parenteral antimicrobial therapy
intervention type: Procedure
intervention name: Outpatient Parenteral Antibiotic Therapy
description: Application of outpatient parenteral antibiotic therapy in patients with infectious diseases to allow them to get discharged from hospital.
arm group label: Outpatient parenteral antimicrobial therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Clara Lehmann, Prof.
role: Study Chair
affiliation: Head of Outpatient Department in ID, University Hospital of Cologne
last name: Clara Lehmann, Prof.
phone: +4922147839684
email: clara.lehmann@uk-koeln.de
last name: Charlotte Leisse
phone: +4922147842895
email: charlotte.leisse@uk-koeln.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Cologne
investigator full name: Clara Lehmann
investigator title: Head of outpatient clinic
mesh term: Anti-Bacterial Agents
sharing ipd: Undecided