<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/NCT04426383</url>
  </required_header>
  <id_info>
    <org_study_id>LMU 20-169</org_study_id>
    <nct_id>NCT04426383</nct_id>
  </id_info>
  <brief_title>Evaluation of a TDM Program for Intensive Care Patients in the Cerebrospinal Fluid</brief_title>
  <acronym>EMIL</acronym>
  <official_title>Evaluation of a TDM Program for Intensive Care Patients in the Cerebrospinal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Freie Universität Berlin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</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>
      Therapeutic drug monitoring of antibiotics in critically ill patients is a present research&#xD;
      topic of the last ten years. Research results have shown subtherapeutic blood concentrations&#xD;
      in those patients. However, the amount of antibiotics in the cerebrospinal fluid (CSF) in&#xD;
      patients with ventriculitis or meningitis is still unclear. This study is a prospective study&#xD;
      to evaluate the concentration of different antibiotics in the CSF in patients with an&#xD;
      external ventricular drainage compared to antibiotic blood concentration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bacterial infections are still associated with a high mortality in intensive care unit&#xD;
      patients. Especially patients diagnosed with ventriculitis caused by a bacterial infection&#xD;
      have a bad outcome. Therefore, antibiotic therapy is the only causal opportunity to treat&#xD;
      those infections. However, there are many chances in pharmacokinetic and -dynamic in&#xD;
      critically ill patients with unpredictable antibiotic concentrations. Furthermore, it is&#xD;
      important that the concentration in the blood as well as in the effect-compartment &quot;CSF&quot; is&#xD;
      sufficient. Less data of the last years describe antibiotic concentrations in the CSF and&#xD;
      show subtherapeutic levels, which is endangering for the therapeutic success. The introduced&#xD;
      study is a prospective, observational study that analyses antibiotic concentrations in CSF in&#xD;
      critically ill patients. The distribution between CSF and blood will be evaluated by&#xD;
      comparing these two compartments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">May 1, 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>28 Days</target_duration>
  <primary_outcome>
    <measure>Incidence of subtherapeutic antibiotic concentrations in cerebrospinal fluid</measure>
    <time_frame>through study completion, on average 2 years</time_frame>
    <description>Percentage of subtherapeutic concentrations of different antibiotics in different subgroups like ventriculitis vs. no ventriculitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>28-day mortality</measure>
    <time_frame>through study completion, on average 2 years</time_frame>
    <description>evaluation of the 28-day mortality in patients with therapeutic and subtherapeutic antibiotic concentrations in cerebrospinal fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of antibiotic concentration in cerebrospinal fluid and C-reactive protein</measure>
    <time_frame>through study completion, on average 2 years</time_frame>
    <description>Correlation of different antibiotic concentrations in patients´ blood and cerebrospinal fluid and the C-reactive protein in the blood. Question of interest is, if therapeutic antibiotic concentration leads to a faster decrease of C-reactive protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of antibiotic concentration in cerebrospinal fluid and interleucin 6</measure>
    <time_frame>through study completion, on average 2 years</time_frame>
    <description>Correlation of different antibiotic concentrations in patients´ blood and cerebrospinal fluid and the interleucin 6 in the blood. Question of interest is, if therapeutic antibiotic concentration leads to a faster decrease of interleucin 6</description>
  </secondary_outcome>
  <enrollment type="Actual">32</enrollment>
  <condition>Ventriculitis, Infectious</condition>
  <eligibility>
    <study_pop>
      <textblock>
        critically ill patients with an external ventricular drainage and the need of antibiotic&#xD;
        therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written approval of the legal guardian&#xD;
&#xD;
          -  external ventricular drainage&#xD;
&#xD;
          -  antibiotic therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no approval&#xD;
&#xD;
          -  no antibiotic therapy or no external ventricular drainage&#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>Michael Zoller</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ludwig-Maximilians - University of Munich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anaesthesiology of the University Hospital of Munich</name>
      <address>
        <city>Munich</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>May 30, 2022</last_update_submitted>
  <last_update_submitted_qc>May 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>Michael Zoller MD</investigator_full_name>
    <investigator_title>senior physician, Department of Anaesthesiology, university hospital munich</investigator_title>
  </responsible_party>
  <keyword>therapeutic drug monitoring (TDM)</keyword>
  <keyword>critically ill patients</keyword>
  <keyword>cerebrospinal fluid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Ventriculitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04426383
org study id: LMU 20-169
nct id: NCT04426383
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Therapeutic drug monitoring of antibiotics in critically ill patients is a present research
      topic of the last ten years. Research results have shown subtherapeutic blood concentrations
      in those patients. However, the amount of antibiotics in the cerebrospinal fluid (CSF) in
      patients with ventriculitis or meningitis is still unclear. This study is a prospective study
      to evaluate the concentration of different antibiotics in the CSF in patients with an
      external ventricular drainage compared to antibiotic blood concentration.
Bacterial infections are still associated with a high mortality in intensive care unit
      patients. Especially patients diagnosed with ventriculitis caused by a bacterial infection
      have a bad outcome. Therefore, antibiotic therapy is the only causal opportunity to treat
      those infections. However, there are many chances in pharmacokinetic and -dynamic in
      critically ill patients with unpredictable antibiotic concentrations. Furthermore, it is
      important that the concentration in the blood as well as in the effect-compartment "CSF" is
      sufficient. Less data of the last years describe antibiotic concentrations in the CSF and
      show subtherapeutic levels, which is endangering for the therapeutic success. The introduced
      study is a prospective, observational study that analyses antibiotic concentrations in CSF in
      critically ill patients. The distribution between CSF and blood will be evaluated by
      comparing these two compartments.
observational model: Cohort
time perspective: Prospective
measure: Incidence of subtherapeutic antibiotic concentrations in cerebrospinal fluid
time frame: through study completion, on average 2 years
description: Percentage of subtherapeutic concentrations of different antibiotics in different subgroups like ventriculitis vs. no ventriculitis
measure: 28-day mortality
time frame: through study completion, on average 2 years
description: evaluation of the 28-day mortality in patients with therapeutic and subtherapeutic antibiotic concentrations in cerebrospinal fluid
measure: Correlation of antibiotic concentration in cerebrospinal fluid and C-reactive protein
time frame: through study completion, on average 2 years
description: Correlation of different antibiotic concentrations in patients´ blood and cerebrospinal fluid and the C-reactive protein in the blood. Question of interest is, if therapeutic antibiotic concentration leads to a faster decrease of C-reactive protein
measure: Correlation of antibiotic concentration in cerebrospinal fluid and interleucin 6
time frame: through study completion, on average 2 years
description: Correlation of different antibiotic concentrations in patients´ blood and cerebrospinal fluid and the interleucin 6 in the blood. Question of interest is, if therapeutic antibiotic concentration leads to a faster decrease of interleucin 6
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Zoller
role: Principal Investigator
affiliation: Ludwig-Maximilians - University of Munich
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: Michael Zoller MD
investigator title: senior physician, Department of Anaesthesiology, university hospital munich
mesh term: Cerebral Ventriculitis
sharing ipd: No