<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/NCT03036826</url>
  </required_header>
  <id_info>
    <org_study_id>CADDy</org_study_id>
    <nct_id>NCT03036826</nct_id>
  </id_info>
  <brief_title>Computer-based Dosage Calculation for Antibiotics</brief_title>
  <official_title>Computer-basierte Dosierungsregime Von Antiinfektiva Bei eingeschränkter Nierenfunktion Und Kontinuierlichen Nierenersatztherapieverfahren (Computer-based Dosage Calculation for Antibiotics in Patients With Impaired Renal Function or Renal Replacement Therapy)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adequate dosing of antiinfective therapy in critically ill patients with impaired or lost&#xD;
      renal function or continuous renal replacement therapy is nearly impossible without measuring&#xD;
      the drug concentration in blood samples. In many hospitals that is still not an option. The&#xD;
      investigators aim to show, that computer based calculation can avoid over- or under-dosing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adequate dosing of antiinfective therapy in critically ill patients is most important to&#xD;
      improve outcome. Patients with impaired or lost renal function or continuous renal&#xD;
      replacement therapy are hard to calculate using drug information sheets or &quot;lists&quot; with&#xD;
      recommendations. It is nearly impossible to avoid drug levels that are much to low or much to&#xD;
      high without measuring the concentration in blood samples. Since that possibility is still&#xD;
      not available in every clinic we aim to show, how a computer based calculation can help to&#xD;
      find the adequate dosing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    due to organisational changes&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2019</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>drug levels (blood)</measure>
    <time_frame>3 days</time_frame>
    <description>achieved drug levels in blood samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>dosing changes</measure>
    <time_frame>3 days</time_frame>
    <description>dose adjustments to the computer based calculated regiments</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Acute Kidney Insufficiency</condition>
  <condition>Anti-Infective Agent Toxicity</condition>
  <arm_group>
    <arm_group_label>Piperacillin/Tazobactam</arm_group_label>
    <description>Group of patients receiving Piperacillin/Tazobactam as antiinfective therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meropenem</arm_group_label>
    <description>Group of patients receiving Meropenem as antiinfective therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Piperacillin/tazobactam</intervention_name>
    <description>antiinfective therapy with Piperacillin/Tazobactam within routine care</description>
    <arm_group_label>Piperacillin/Tazobactam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Meropenem</intervention_name>
    <description>antiinfective therapy with Meropenem within routine care</description>
    <arm_group_label>Meropenem</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        critically ill patients with impaired renal function and antiinfective therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients requiring antiinfective therapy&#xD;
&#xD;
          -  patients with impaired renal function or requiring continuous renal replacement&#xD;
             therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  plasmapheresis or liver replacement therapy&#xD;
&#xD;
          -  renal replacement therapy with integrated CytoSorb®-Membrane&#xD;
&#xD;
          -  extracorporal live support&#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>Stefanie Prohaska, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Tuebingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>December 19, 2019</last_update_submitted>
  <last_update_submitted_qc>December 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>renal replacement therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meropenem</mesh_term>
    <mesh_term>Tazobactam</mesh_term>
    <mesh_term>Piperacillin</mesh_term>
    <mesh_term>Piperacillin, Tazobactam Drug Combination</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/NCT03036826
org study id: CADDy
nct id: NCT03036826
lead sponsor: 
has dmc: Yes
Adequate dosing of antiinfective therapy in critically ill patients with impaired or lost
      renal function or continuous renal replacement therapy is nearly impossible without measuring
      the drug concentration in blood samples. In many hospitals that is still not an option. The
      investigators aim to show, that computer based calculation can avoid over- or under-dosing.
Adequate dosing of antiinfective therapy in critically ill patients is most important to
      improve outcome. Patients with impaired or lost renal function or continuous renal
      replacement therapy are hard to calculate using drug information sheets or "lists" with
      recommendations. It is nearly impossible to avoid drug levels that are much to low or much to
      high without measuring the concentration in blood samples. Since that possibility is still
      not available in every clinic we aim to show, how a computer based calculation can help to
      find the adequate dosing.
observational model: Cohort
time perspective: Prospective
measure: drug levels (blood)
time frame: 3 days
description: achieved drug levels in blood samples
measure: dosing changes
time frame: 3 days
description: dose adjustments to the computer based calculated regiments
arm group label: Piperacillin/Tazobactam
description: Group of patients receiving Piperacillin/Tazobactam as antiinfective therapy
arm group label: Meropenem
description: Group of patients receiving Meropenem as antiinfective therapy
intervention type: Drug
intervention name: Piperacillin/tazobactam
description: antiinfective therapy with Piperacillin/Tazobactam within routine care
arm group label: Piperacillin/Tazobactam
intervention type: Drug
intervention name: Meropenem
description: antiinfective therapy with Meropenem within routine care
arm group label: Meropenem
blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefanie Prohaska, MD
role: Principal Investigator
affiliation: University Hospital Tuebingen
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Acute Kidney Injury
mesh term: Meropenem
mesh term: Tazobactam
mesh term: Piperacillin
mesh term: Piperacillin, Tazobactam Drug Combination
sharing ipd: Undecided