<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/NCT02255318</url>
  </required_header>
  <id_info>
    <org_study_id>2013-792</org_study_id>
    <nct_id>NCT02255318</nct_id>
  </id_info>
  <brief_title>Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition</brief_title>
  <official_title>Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The therapeutic management of patients with cancer often requires the establishment of a&#xD;
      chamber implantable catheter. Infections are the main complication of these catheters. These&#xD;
      infections may be responsible for a significant impairment of quality of life for patients,&#xD;
      and may increase the frequency and duration of hospitalizations. The rate of mortality from&#xD;
      these infections is about 17%. The objective of this study is to evaluate the efficacy of a&#xD;
      1.35% taurolidine lock / 4% citrate (TauroLock®) in the primary prevention of infections&#xD;
      related to chambers implantable catheter (IRCIC) in cancer patients receiving parenteral&#xD;
      nutrition.&#xD;
&#xD;
      This is a, randomized, double-blind clinical trial comparing the incidence of IRCIC in&#xD;
      patients receiving Taurolidine lock or concession the usual procedure of rinsing with saline&#xD;
      (placebo) (pulsed rinsing with 20 mL of serum physiological and clamping catheter positive&#xD;
      pressure). The lock will be instilled after the end of the session IV treatment&#xD;
      (chemotherapy, parenteral nutrition, transfusion) before closing the catheter. The primary&#xD;
      endpoint will be the rate IRCIC in both groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence rate of infections related to chamber implantable catheters (IRCIC) in patients who received Taurolock® versus those who received the usual procedure of saline flush.</measure>
    <time_frame>The incidence will be assessed between the inclusion and 3 months after the beginning of the study.</time_frame>
    <description>Definition of IRCIC This definition of infections related to chamber implantable catheters will be used for all patients. It is based on the identification of the same germ blood cultures of peripheral vein and those of the central venous line with a differential time greater than 120 minutes growth.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delay onset of IRCIC</measure>
    <time_frame>between the inclusion and 3 months after the beginning of the study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalizations for IRCIC.</measure>
    <time_frame>between the inclusion and 3 months after the beginning of the study</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Cancer</condition>
  <condition>Infection</condition>
  <arm_group>
    <arm_group_label>Taurolock</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received Taurolock lock for 3 months administration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients received placebo lock (physiological serum) for 3 months administration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Taurolock</intervention_name>
    <arm_group_label>Taurolock</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 years and over&#xD;
&#xD;
          -  Patients with solid cancer&#xD;
&#xD;
          -  Patients with implantable catheter&#xD;
&#xD;
          -  Patients receiving parenteral nutrition&#xD;
&#xD;
          -  Patient affiliated to a social security scheme or beneficiary of such a regime&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients refusing to participate in the protocol&#xD;
&#xD;
          -  Patients already receiving preventive lock of IRCIC&#xD;
&#xD;
          -  Known citrate or (cyclo) allergy -taurolidine&#xD;
&#xD;
          -  Patients taking other drugs with known contraindications against the citrate or&#xD;
             cyclotaurolidine.&#xD;
&#xD;
          -  Participation in another protocol for the prevention of infections associated with&#xD;
             central venous catheters&#xD;
&#xD;
          -  Patients who did not sign the consent&#xD;
&#xD;
          -  Patient with a status of socio-legal protection&#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>Cécile CHAMBRIER, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cécile CHAMBRIER, PH</last_name>
    <phone>4.72 00 15 25</phone>
    <phone_ext>+33</phone_ext>
    <email>cecile.chambrier@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Isabelle DELFOUR</last_name>
    <phone>4.26.73.27.25</phone>
    <phone_ext>+33</phone_ext>
    <email>isabelle.delfour@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Edouard Herriot</name>
      <address>
        <city>France</city>
        <state>Lyon</state>
        <zip>69003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julien Forestier</last_name>
      <email>julien.forestier@chu-lyon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Croix Rousse</name>
      <address>
        <city>France</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marielle GUILLET</last_name>
      <email>marielle.guillet@chu-lyon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Groupement Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre Bénite</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marion Chauvenet</last_name>
      <email>marion.chauvenet@chu-lyon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>October 27, 2016</last_update_submitted>
  <last_update_submitted_qc>October 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Taurolock®</keyword>
  <keyword>infections related to chambers implantable catheter</keyword>
  <keyword>patients with cancer receiving parenteral nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT02255318
org study id: 2013-792
nct id: NCT02255318
lead sponsor: 
has dmc: No
The therapeutic management of patients with cancer often requires the establishment of a
      chamber implantable catheter. Infections are the main complication of these catheters. These
      infections may be responsible for a significant impairment of quality of life for patients,
      and may increase the frequency and duration of hospitalizations. The rate of mortality from
      these infections is about 17%. The objective of this study is to evaluate the efficacy of a
      1.35% taurolidine lock / 4% citrate (TauroLock®) in the primary prevention of infections
      related to chambers implantable catheter (IRCIC) in cancer patients receiving parenteral
      nutrition.

      This is a, randomized, double-blind clinical trial comparing the incidence of IRCIC in
      patients receiving Taurolidine lock or concession the usual procedure of rinsing with saline
      (placebo) (pulsed rinsing with 20 mL of serum physiological and clamping catheter positive
      pressure). The lock will be instilled after the end of the session IV treatment
      (chemotherapy, parenteral nutrition, transfusion) before closing the catheter. The primary
      endpoint will be the rate IRCIC in both groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: The incidence rate of infections related to chamber implantable catheters (IRCIC) in patients who received Taurolock® versus those who received the usual procedure of saline flush.
time frame: The incidence will be assessed between the inclusion and 3 months after the beginning of the study.
description: Definition of IRCIC This definition of infections related to chamber implantable catheters will be used for all patients. It is based on the identification of the same germ blood cultures of peripheral vein and those of the central venous line with a differential time greater than 120 minutes growth.
measure: Delay onset of IRCIC
time frame: between the inclusion and 3 months after the beginning of the study
measure: Duration of hospitalizations for IRCIC.
time frame: between the inclusion and 3 months after the beginning of the study
arm group label: Taurolock
arm group type: Experimental
description: Patients received Taurolock lock for 3 months administration.
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients received placebo lock (physiological serum) for 3 months administration.
intervention type: Device
intervention name: Taurolock
arm group label: Taurolock
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cécile CHAMBRIER, PH
role: Principal Investigator
affiliation: Hospices Civils de Lyon
last name: Cécile CHAMBRIER, PH
phone: 4.72 00 15 25
phone ext: +33
email: cecile.chambrier@chu-lyon.fr
last name: Isabelle DELFOUR
phone: 4.26.73.27.25
phone ext: +33
email: isabelle.delfour@chu-lyon.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases