<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/NCT02967341</url>
  </required_header>
  <id_info>
    <org_study_id>Safepedrug-02</org_study_id>
    <nct_id>NCT02967341</nct_id>
  </id_info>
  <brief_title>Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients</brief_title>
  <official_title>Validation of Central Venous (Port A Cath®) Blood Draws for Ciprofloxacin Pharmacokinetic Research in Patients Under Treatment for Childhood Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To validate blood draws via a central venous catheter (Port A Cath ®) for pharmacokinetic&#xD;
      studies of ciprofloxacin in patients under treatment for childhood cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The concentration of cipro will be determined using a validated high-performance liquid&#xD;
      chromatographic (HPLC) method with fluorescence detection. Unbound concentration will be&#xD;
      determined by adjusting the pH of the plasma samples to physiological pH (7.4) in a CO2&#xD;
      incubator, followed by ultrafiltration and extraction of ciprofloxacin from the ultrafiltrate&#xD;
      (as described above) prior to injection onto the HPLC system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction</measure>
    <time_frame>1 hour</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Childhood Cancer</condition>
  <condition>Neutropenia</condition>
  <arm_group>
    <arm_group_label>Ciprofloxacin administration</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Blood will be drawn, in all participants, via Port A Cath and via a peripheral draw.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ciprofloxacin administration</intervention_name>
    <description>Ciprofloxacin will be administered via the PAC directly followed by a NaCl 0.9% flush to wash the PAC. At least 1 hour afterwards 500 microliter of blood will be drawn via the PAC. Directly hereafter a blood draw of 500 microliter will be performed either via capillary blood sampling or via a venipuncture. If an anaesthesia is foreseen for another procedure (e.g. a lumbar puncture or an osseous punction), we will strive to perform the peripheral blood draw under anaesthesia.</description>
    <arm_group_label>Ciprofloxacin administration</arm_group_label>
    <other_name>Ciprofloxacin</other_name>
    <other_name>Port A Cath (PAC)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Children who&#xD;
&#xD;
          -  are between 1 month and 18 years of age&#xD;
&#xD;
          -  are under treatment for any type of childhood cancer&#xD;
&#xD;
          -  use ciprofloxacin for prophylaxis of febrile neutropenia as part of regular treatment&#xD;
&#xD;
          -  have a PAC for intravenous medication and blood draws.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Children will be excluded from this study if we are unable to&#xD;
&#xD;
          -  obtain informed consent of both parents and assent of the child (if he/she is over 12&#xD;
             years of age)&#xD;
&#xD;
          -  aspire blood from the PAC.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jutte van der Werff ten Bosch, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitair Ziekenhuis Brussel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kevin Meesters, MD MPH</last_name>
    <email>kevin.meesters@uzbrussel.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Brussel</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jutte van der Werff ten Bosch, MD PhD</last_name>
      <email>Jutte.VanderWerffTenBosch@uzbrussel.be</email>
    </contact>
    <contact_backup>
      <last_name>Kevin Meesters, MD MPH</last_name>
      <email>kevin.meesters@uzbrussel.be</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 15, 2016</last_update_submitted>
  <last_update_submitted_qc>November 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neutropenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ciprofloxacin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02967341
org study id: Safepedrug-02
nct id: NCT02967341
lead sponsor: 
has dmc: Yes
To validate blood draws via a central venous catheter (Port A Cath ®) for pharmacokinetic
      studies of ciprofloxacin in patients under treatment for childhood cancer.
The concentration of cipro will be determined using a validated high-performance liquid
      chromatographic (HPLC) method with fluorescence detection. Unbound concentration will be
      determined by adjusting the pH of the plasma samples to physiological pH (7.4) in a CO2
      incubator, followed by ultrafiltration and extraction of ciprofloxacin from the ultrafiltrate
      (as described above) prior to injection onto the HPLC system.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction
time frame: 1 hour
arm group label: Ciprofloxacin administration
arm group type: Other
description: Blood will be drawn, in all participants, via Port A Cath and via a peripheral draw.
intervention type: Other
intervention name: Ciprofloxacin administration
description: Ciprofloxacin will be administered via the PAC directly followed by a NaCl 0.9% flush to wash the PAC. At least 1 hour afterwards 500 microliter of blood will be drawn via the PAC. Directly hereafter a blood draw of 500 microliter will be performed either via capillary blood sampling or via a venipuncture. If an anaesthesia is foreseen for another procedure (e.g. a lumbar puncture or an osseous punction), we will strive to perform the peripheral blood draw under anaesthesia.
arm group label: Ciprofloxacin administration
other name: Ciprofloxacin
other name: Port A Cath (PAC)
criteria: 
gender: All
minimum age: 1 Month
maximum age: 17 Years
healthy volunteers: No
last name: Jutte van der Werff ten Bosch, MD PhD
role: Principal Investigator
affiliation: Universitair Ziekenhuis Brussel
last name: Kevin Meesters, MD MPH
email: kevin.meesters@uzbrussel.be
facility: 
status: Recruiting
contact: 
contact backup: 
country: Belgium
responsible party type: Sponsor
mesh term: Neutropenia
mesh term: Ciprofloxacin
sharing ipd: Yes