<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/NCT03016845</url>
  </required_header>
  <id_info>
    <org_study_id>UMCN-AFK 16.07</org_study_id>
    <nct_id>NCT03016845</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Ciprofloxacin in Critically Ill Patients</brief_title>
  <acronym>CAPOEIRA</acronym>
  <official_title>Pharmacokinetics of Ciprofloxacin in Critically Ill Patients - a Screening Study to Assess the Feasibility of Renal Function Markers to Predict Ciprofloxacin Clearance (CAPOEIRA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canisius-Wilhelmina Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gelderse Vallei Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tergooi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</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>
      Optimal understanding of ciprofloxacin pharmacokinetics in critically ill patients is lacking&#xD;
      resulting in large variation of achieved exposure and possible inadequate therapy. The&#xD;
      investigators hypothesize that drug dosing based on CKD-EPIcr-cys provides a useful method to&#xD;
      individualize and optimize therapy for ciprofloxacin and eventually improve outcome.&#xD;
&#xD;
      In a multi-centre, observational, open-label study the investigators aim to define : the&#xD;
      model for estimation of renal function that most accurately predicts ciprofloxacin clearance&#xD;
      in critically ill patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Correct estimation of glomerular filtration rate (GFR) is necessary in critically ill&#xD;
      patients in order to asses renal function. GFR is subsequently used to derive and appropriate&#xD;
      drug dosing of renally excreted drugs and warrant adequate dose adaptations.&#xD;
&#xD;
      It is known that estimation of GFR based on creatinine clearance is not precise, especially&#xD;
      in populations with altered muscle mass or instable renal function, such as the Intensive&#xD;
      Care Unit (ICU) population.&#xD;
&#xD;
      The use of combined filtration markers together, cystatin C and creatinine, can improve&#xD;
      precision in estimating GFR (eGFR). Studies confirmed that eGFR based on both creatinine and&#xD;
      cystatin C is more precise than eGFR creatinine or eGFR cystatin C. The equation based on&#xD;
      both creatinine and cystatin C, the Chronic Kidney Disease Epidemiology Collaboration&#xD;
      creatinine-cystatin C (CKD-EPIcr-cys), may therefore improve eGFR and thus drug dosing in ICU&#xD;
      patients, a population that does not reach PK/PD targets frequently.&#xD;
&#xD;
      So far little is known about drug dosing based on CKD-EPIcr-cys. Currently optimal&#xD;
      understanding of ciprofloxacin pharmacokinetics in critically ill patients is lacking,&#xD;
      resulting in large variation of achieved exposure and possible inadequate therapy. The&#xD;
      investigators hypothesize that drug dosing based on CKD-EPIcr-cys provides a useful method to&#xD;
      individualize and optimize therapy for ciprofloxacin and eventually improve outcome.&#xD;
&#xD;
      In a multi-centre, observational, open-label study the investigators aim to define the model&#xD;
      for estimation of renal function that most accurately predicts ciprofloxacin clearance in&#xD;
      critically ill patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</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>model for estimation of renal function that most accurately predicts ciprofloxacin clearance</measure>
    <time_frame>Day 1 and day 2</time_frame>
    <description>Full pharmacokinetic curves will be taken on Day 1 and Day 2</description>
  </primary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Bacterial Infections</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma samples for determination of ciprofloxacin and cystatin C Urine for measuring 24h&#xD;
      creatinine cleaurance&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients receiving ciprofloxacin for treating a suspected or proven bacterial infection&#xD;
        at the ICU will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is admitted to an ICU&#xD;
&#xD;
          2. Subject is at least 18 years on the day of the first dosing&#xD;
&#xD;
          3. Is managed with an arterial line or central venous catheter&#xD;
&#xD;
          4. Is managed with an urinary catheter&#xD;
&#xD;
          5. Is already treated with ciprofloxacin as part of routine clinical care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has previously participated in this study&#xD;
&#xD;
          2. Is on renal replacement therapy (RRT)&#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>Roger Bruggemann</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ziekenhuis Gelderse Vallei</name>
      <address>
        <city>Ede</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CWZ</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC Utrecht</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/32298468/</url>
    <description>paper</description>
  </link>
  <results_reference>
    <citation>Gieling EM, Wallenburg E, Frenzel T, de Lange DW, Schouten JA, Ten Oever J, Kolwijck E, Burger DM, Pickkers P, Ter Heine R, Bruggemann RJM. Higher Dosage of Ciprofloxacin Necessary in Critically Ill Patients: A New Dosing Algorithm Based on Renal Function and Pathogen Susceptibility. Clin Pharmacol Ther. 2020 Oct;108(4):770-774. doi: 10.1002/cpt.1855. Epub 2020 May 15.</citation>
    <PMID>32298468</PMID>
  </results_reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>October 16, 2020</last_update_submitted>
  <last_update_submitted_qc>October 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ciprofloxacin</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>Intensive Care Unit</keyword>
  <keyword>Cystatin C</keyword>
  <keyword>CKD-EPI</keyword>
  <keyword>renal function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacterial Infections</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/NCT03016845
org study id: UMCN-AFK 16.07
nct id: NCT03016845
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Optimal understanding of ciprofloxacin pharmacokinetics in critically ill patients is lacking
      resulting in large variation of achieved exposure and possible inadequate therapy. The
      investigators hypothesize that drug dosing based on CKD-EPIcr-cys provides a useful method to
      individualize and optimize therapy for ciprofloxacin and eventually improve outcome.

      In a multi-centre, observational, open-label study the investigators aim to define : the
      model for estimation of renal function that most accurately predicts ciprofloxacin clearance
      in critically ill patients.
Correct estimation of glomerular filtration rate (GFR) is necessary in critically ill
      patients in order to asses renal function. GFR is subsequently used to derive and appropriate
      drug dosing of renally excreted drugs and warrant adequate dose adaptations.

      It is known that estimation of GFR based on creatinine clearance is not precise, especially
      in populations with altered muscle mass or instable renal function, such as the Intensive
      Care Unit (ICU) population.

      The use of combined filtration markers together, cystatin C and creatinine, can improve
      precision in estimating GFR (eGFR). Studies confirmed that eGFR based on both creatinine and
      cystatin C is more precise than eGFR creatinine or eGFR cystatin C. The equation based on
      both creatinine and cystatin C, the Chronic Kidney Disease Epidemiology Collaboration
      creatinine-cystatin C (CKD-EPIcr-cys), may therefore improve eGFR and thus drug dosing in ICU
      patients, a population that does not reach PK/PD targets frequently.

      So far little is known about drug dosing based on CKD-EPIcr-cys. Currently optimal
      understanding of ciprofloxacin pharmacokinetics in critically ill patients is lacking,
      resulting in large variation of achieved exposure and possible inadequate therapy. The
      investigators hypothesize that drug dosing based on CKD-EPIcr-cys provides a useful method to
      individualize and optimize therapy for ciprofloxacin and eventually improve outcome.

      In a multi-centre, observational, open-label study the investigators aim to define the model
      for estimation of renal function that most accurately predicts ciprofloxacin clearance in
      critically ill patients.
observational model: Case-Only
time perspective: Prospective
measure: model for estimation of renal function that most accurately predicts ciprofloxacin clearance
time frame: Day 1 and day 2
description: Full pharmacokinetic curves will be taken on Day 1 and Day 2
plasma samples for determination of ciprofloxacin and cystatin C Urine for measuring 24h
      creatinine cleaurance
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roger Bruggemann
role: Principal Investigator
affiliation: Radboud University Medical Center
facility: 
facility: 
facility: 
facility: 
country: Netherlands
url: https://pubmed.ncbi.nlm.nih.gov/32298468/
description: paper
citation: Gieling EM, Wallenburg E, Frenzel T, de Lange DW, Schouten JA, Ten Oever J, Kolwijck E, Burger DM, Pickkers P, Ter Heine R, Bruggemann RJM. Higher Dosage of Ciprofloxacin Necessary in Critically Ill Patients: A New Dosing Algorithm Based on Renal Function and Pathogen Susceptibility. Clin Pharmacol Ther. 2020 Oct;108(4):770-774. doi: 10.1002/cpt.1855. Epub 2020 May 15.
PMID: 32298468
responsible party type: Sponsor
mesh term: Bacterial Infections
sharing ipd: No