<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/NCT01702545</url>
  </required_header>
  <id_info>
    <org_study_id>PEAK-001</org_study_id>
    <nct_id>NCT01702545</nct_id>
  </id_info>
  <brief_title>Determination of Drugs and Their Metabolites in Hospitalized Patients</brief_title>
  <official_title>Determination of Drugs and Their Metabolites in Hospitalized Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klinikum Nürnberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Klinikum Nürnberg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current state of knowledge on the concentration of drugs and their metabolites in the&#xD;
      individual human body is not satisfying concerning the question about behavior of drugs in&#xD;
      the human body, taking into account individual patient factors such as age, weight and organ&#xD;
      dysfunctions.&#xD;
&#xD;
      This projects deals with the question of drug levels in the blood of hospitalized patients.&#xD;
&#xD;
      The aim of this study is to extend the knowledge about the behavior of drugs in the human&#xD;
      body significantly, for the safety and benefit of future patients. This also includes to&#xD;
      establish a relationship between drug levels in patients and the desired and undesired&#xD;
      effects of a drug.&#xD;
&#xD;
      As a result, the future perspective is to find the optimal dose for the individual patient by&#xD;
      measuring the blood concentration of a drug.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary goal of the study is to gain an overview of the plasma concentrations of relevant&#xD;
      drugs which occur in different patient populations and to what extent they are consistent&#xD;
      with those concentrations described in the literature.&#xD;
&#xD;
      If the expectation is confirmed, that a significant heterogeneity in the plasma&#xD;
      concentrations of these patients exists, the investigators will try to find influencing&#xD;
      factors for this circumstance on the basis of routine clinical parameters (height, weight,&#xD;
      renal function, concomitant medications, etc.).&#xD;
&#xD;
      Ultimately, this project will identify substances with a high interindividual variability in&#xD;
      plasma levels, where drug monitoring might be suggested.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Plasma concentrations [ng/mL] of various drugs at different timepoints</measure>
    <time_frame>up to five years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Neoplasms</condition>
  <biospec_descr>
    <textblock>
      Blood, Plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  legal capacity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe anemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Wilhelm, Prof Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Paracelsus Medical University Klinikum Nuremberg, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martin Wilhelm, Prof. Dr.</last_name>
    <phone>00499113983050</phone>
    <email>martin.wilhelm@klinikum-nuernberg.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Martin Wilhelm, Prof Dr</last_name>
    <phone>00499113983050</phone>
    <email>martin.wilhelm@klinikum-nuernberg.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dept. of Internal Medicine V, Klinikum Nürnberg Nord</name>
      <address>
        <city>Nürnberg</city>
        <state>Bavaria</state>
        <zip>90419</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Wilhelm, Prof. Dr.</last_name>
      <phone>00499113983050</phone>
      <email>martin.wilhelm@klinikum-nuernberg.de</email>
    </contact>
    <investigator>
      <last_name>Martin Wilhelm, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Klinikum Nürnberg</investigator_affiliation>
    <investigator_full_name>Mr. Prof. Dr. Wilhelm</investigator_full_name>
    <investigator_title>Prof. Dr. med. Martin Wilhelm</investigator_title>
  </responsible_party>
  <!-- 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/NCT01702545
org study id: PEAK-001
nct id: NCT01702545
lead sponsor: 
has dmc: No
The current state of knowledge on the concentration of drugs and their metabolites in the
      individual human body is not satisfying concerning the question about behavior of drugs in
      the human body, taking into account individual patient factors such as age, weight and organ
      dysfunctions.

      This projects deals with the question of drug levels in the blood of hospitalized patients.

      The aim of this study is to extend the knowledge about the behavior of drugs in the human
      body significantly, for the safety and benefit of future patients. This also includes to
      establish a relationship between drug levels in patients and the desired and undesired
      effects of a drug.

      As a result, the future perspective is to find the optimal dose for the individual patient by
      measuring the blood concentration of a drug.
The primary goal of the study is to gain an overview of the plasma concentrations of relevant
      drugs which occur in different patient populations and to what extent they are consistent
      with those concentrations described in the literature.

      If the expectation is confirmed, that a significant heterogeneity in the plasma
      concentrations of these patients exists, the investigators will try to find influencing
      factors for this circumstance on the basis of routine clinical parameters (height, weight,
      renal function, concomitant medications, etc.).

      Ultimately, this project will identify substances with a high interindividual variability in
      plasma levels, where drug monitoring might be suggested.
observational model: Case-Only
time perspective: Prospective
measure: Plasma concentrations [ng/mL] of various drugs at different timepoints
time frame: up to five years
Blood, Plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Martin Wilhelm, Prof Dr.
role: Study Chair
affiliation: Paracelsus Medical University Klinikum Nuremberg, Germany
last name: Martin Wilhelm, Prof. Dr.
phone: 00499113983050
email: martin.wilhelm@klinikum-nuernberg.de
last name: Martin Wilhelm, Prof Dr
phone: 00499113983050
email: martin.wilhelm@klinikum-nuernberg.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Klinikum Nürnberg
investigator full name: Mr. Prof. Dr. Wilhelm
investigator title: Prof. Dr. med. Martin Wilhelm