<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/NCT01714570</url>
  </required_header>
  <id_info>
    <org_study_id>PTZ-20120702</org_study_id>
    <nct_id>NCT01714570</nct_id>
  </id_info>
  <brief_title>Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia</brief_title>
  <official_title>A Prospective, Randomized, Open Label Study of Piperacillin/Tazobactam Versus Imipenem/Cilastin for Empirical Therapy of Febrile Patients With Neutropenia After Hematopoietic Stem Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neutropenia is very common in patients received hematopoietic stem cell transplantation, with&#xD;
      median duration of about 14 days. In 2010 update, IDSA recommended Piperacillin/tazobactam as&#xD;
      first-line mono-therapy for febrile patients with neutropenia of high risk. In china, the&#xD;
      data of piperacillin/tazobactam for febrile neutropenia after hematopoietic stem cell&#xD;
      transplantation is very limited.&#xD;
&#xD;
      The current study will evaluate the efficacy of piperacillin/tazobactam compared with&#xD;
      imipenem/cilastatin for febrile neutropenia after transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room&#xD;
           after transplantation.&#xD;
&#xD;
        2. Randomize the febrile patients into 2 groups.&#xD;
&#xD;
        3. Therapy group receive piperacillin/tazobactam, 4.5g q6h iv. Control group receive&#xD;
           imipenem/cilastatin, 0.5g q6h. Duration will be 5-10 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical success rate.</measure>
    <time_frame>3 weeks after beginning of empirical therapy</time_frame>
    <description>Resolve of clinical symptoms and signs, without change of therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microbiologic success rate</measure>
    <time_frame>3 weeks after beginning of empirical therapy</time_frame>
    <description>Microbiologic success includes eradication, suspected eradication, and super-infection.&#xD;
Eradication or Presumed eradication: the baseline pathogens no longer present on the culture performed after completion of treatment. If no way to collect biologic sample(s) after treatment;, e.g. sputum, a presumed eradication will be concluded&#xD;
No eradication: one or more baseline pathogens were persistent&#xD;
Relapse: the baseline pathogens transient absence reappeared during the therapy&#xD;
Alternative: the baseline pathogens were eradicated, but new ones appeared without any clinical signs and symptoms&#xD;
Re-infection: the baseline pathogens were eradicated, but new ones appeared with clinical signs and symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effect</measure>
    <time_frame>3 weeks after beginning of empirical therapy</time_frame>
    <description>The number of patients developed unexpected medical information at the 3 weeks after beginning of empirical therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of drug and therapy</measure>
    <time_frame>3 weeks after beginning of empirical therapy</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Febrile</condition>
  <condition>Neutropenia</condition>
  <condition>Hematopoietic Stem Cell Transplantation</condition>
  <arm_group>
    <arm_group_label>piperacillin/tazobactam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>imipenem/cilastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Piperacillin-tazobactam combination product</intervention_name>
    <description>4.5g q6h, 5-10 days</description>
    <arm_group_label>piperacillin/tazobactam</arm_group_label>
    <other_name>Tazocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imipenem</intervention_name>
    <description>0.5g q6h, 5-10 days</description>
    <arm_group_label>imipenem/cilastatin</arm_group_label>
    <other_name>Tienam</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 13-65 years&#xD;
&#xD;
          -  received Autologous or Allogeneic hematopoietic stem cell transplantation.&#xD;
&#xD;
          -  ECOG score 0-1.&#xD;
&#xD;
          -  ICF is available.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic to any therapy drug.&#xD;
&#xD;
          -  Documented infection before neutropenia.&#xD;
&#xD;
          -  Renal dysfunction.&#xD;
&#xD;
          -  Suffering from central nervous system or mental disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>wenrong huang, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Employee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chinese PLA general hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>July 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>April 16, 2014</last_update_submitted>
  <last_update_submitted_qc>April 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Wenrong Huang</investigator_full_name>
    <investigator_title>Associate director, Hematology, Chinese PLA General hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neutropenia</mesh_term>
    <mesh_term>Hyperthermia</mesh_term>
    <mesh_term>Fever</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tazobactam</mesh_term>
    <mesh_term>Piperacillin</mesh_term>
    <mesh_term>Imipenem</mesh_term>
    <mesh_term>Piperacillin, Tazobactam Drug Combination</mesh_term>
  </intervention_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/NCT01714570
org study id: PTZ-20120702
nct id: NCT01714570
lead sponsor: 
has dmc: Yes
Neutropenia is very common in patients received hematopoietic stem cell transplantation, with
      median duration of about 14 days. In 2010 update, IDSA recommended Piperacillin/tazobactam as
      first-line mono-therapy for febrile patients with neutropenia of high risk. In china, the
      data of piperacillin/tazobactam for febrile neutropenia after hematopoietic stem cell
      transplantation is very limited.

      The current study will evaluate the efficacy of piperacillin/tazobactam compared with
      imipenem/cilastatin for febrile neutropenia after transplantation.
1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room
           after transplantation.

        2. Randomize the febrile patients into 2 groups.

        3. Therapy group receive piperacillin/tazobactam, 4.5g q6h iv. Control group receive
           imipenem/cilastatin, 0.5g q6h. Duration will be 5-10 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical success rate.
time frame: 3 weeks after beginning of empirical therapy
description: Resolve of clinical symptoms and signs, without change of therapy.
measure: Microbiologic success rate
time frame: 3 weeks after beginning of empirical therapy
description: Microbiologic success includes eradication, suspected eradication, and super-infection.
Eradication or Presumed eradication: the baseline pathogens no longer present on the culture performed after completion of treatment. If no way to collect biologic sample(s) after treatment;, e.g. sputum, a presumed eradication will be concluded
No eradication: one or more baseline pathogens were persistent
Relapse: the baseline pathogens transient absence reappeared during the therapy
Alternative: the baseline pathogens were eradicated, but new ones appeared without any clinical signs and symptoms
Re-infection: the baseline pathogens were eradicated, but new ones appeared with clinical signs and symptoms.
measure: Adverse effect
time frame: 3 weeks after beginning of empirical therapy
description: The number of patients developed unexpected medical information at the 3 weeks after beginning of empirical therapy.
measure: Cost of drug and therapy
time frame: 3 weeks after beginning of empirical therapy
arm group label: piperacillin/tazobactam
arm group type: Experimental
arm group label: imipenem/cilastatin
arm group type: Active Comparator
intervention type: Drug
intervention name: Piperacillin-tazobactam combination product
description: 4.5g q6h, 5-10 days
arm group label: piperacillin/tazobactam
other name: Tazocin
intervention type: Drug
intervention name: Imipenem
description: 0.5g q6h, 5-10 days
arm group label: imipenem/cilastatin
other name: Tienam
criteria: 
gender: All
minimum age: 13 Years
maximum age: 65 Years
healthy volunteers: No
last name: wenrong huang, Doctor
role: Principal Investigator
affiliation: Employee
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Wenrong Huang
investigator title: Associate director, Hematology, Chinese PLA General hospital
mesh term: Neutropenia
mesh term: Hyperthermia
mesh term: Fever
mesh term: Tazobactam
mesh term: Piperacillin
mesh term: Imipenem
mesh term: Piperacillin, Tazobactam Drug Combination