<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/NCT01669005</url>
  </required_header>
  <id_info>
    <org_study_id>EK 324/06</org_study_id>
    <nct_id>NCT01669005</nct_id>
  </id_info>
  <brief_title>The Utility of Multiplex PCR for Detection of DNA in Neutropenic Patients With Hematological Malignancies</brief_title>
  <acronym>MedIso</acronym>
  <official_title>Obtaining Early Diagnosis and Prognosis in Urgent Sepsis (OEDIPUS) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire Vaudois</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: Invasive infections are the leading cause of morbidity and mortality in patients&#xD;
      treated for hematological malignancies. Blood cultures are often negative in neutropenic&#xD;
      patients because of low-burden of organisms, previous antibiotic therapy or non-infectious&#xD;
      reason of fever. More rapid, accurate and sensitive diagnostic tools are needed.&#xD;
&#xD;
      Hypothesis: Multiplex real-time PCR may detect microbial DNA in neutropenic patients before&#xD;
      febrile episode. To investigate this hypothesis, EDTA-blood was routinely collected for&#xD;
      multiplex PCR at admission and 3x/week thereafter until discharge or recovery from&#xD;
      neutropenia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2007</start_date>
  <completion_date type="Actual">December 2008</completion_date>
  <primary_completion_date type="Actual">December 2008</primary_completion_date>
  <study_type>Observational</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>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">84</enrollment>
  <condition>Neutropenia</condition>
  <arm_group>
    <arm_group_label>Bone marrow transplant unit patients</arm_group_label>
    <description>hospitalized patients in the bone marrow transplant unit for an autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      3 ml of EDTA-blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized in the bone marrow transplant unit in the study period&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged ≥18 years&#xD;
&#xD;
          -  autologous or allogeneic hematopoietic stem cells transplantation or&#xD;
             induction/consolidation chemotherapy performed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No blood samples were taken&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrej Trampuz, MD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital Lausanne, Switzerland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christina Orasch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Lausanne, Switzerland</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>August 17, 2012</last_update_submitted>
  <last_update_submitted_qc>August 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
    <investigator_full_name>Andrej Trampuz</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>neutropenia</keyword>
  <keyword>multiplex PCR</keyword>
  <keyword>infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neutropenia</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/NCT01669005
org study id: EK 324/06
nct id: NCT01669005
lead sponsor: 
collaborator: 
has dmc: No
Objectives: Invasive infections are the leading cause of morbidity and mortality in patients
      treated for hematological malignancies. Blood cultures are often negative in neutropenic
      patients because of low-burden of organisms, previous antibiotic therapy or non-infectious
      reason of fever. More rapid, accurate and sensitive diagnostic tools are needed.

      Hypothesis: Multiplex real-time PCR may detect microbial DNA in neutropenic patients before
      febrile episode. To investigate this hypothesis, EDTA-blood was routinely collected for
      multiplex PCR at admission and 3x/week thereafter until discharge or recovery from
      neutropenia
observational model: Cohort
time perspective: Prospective
arm group label: Bone marrow transplant unit patients
description: hospitalized patients in the bone marrow transplant unit for an autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy
3 ml of EDTA-blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Andrej Trampuz, MD
role: Study Director
affiliation: University Hospital Lausanne, Switzerland
last name: Christina Orasch, MD
role: Principal Investigator
affiliation: University Hospital Lausanne, Switzerland
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire Vaudois
investigator full name: Andrej Trampuz
investigator title: MD
mesh term: Neutropenia