<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/NCT01714557</url>
  </required_header>
  <id_info>
    <org_study_id>TZP-HEM-20120608</org_study_id>
    <nct_id>NCT01714557</nct_id>
  </id_info>
  <brief_title>Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation</brief_title>
  <official_title>Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study</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>No</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. Almost all neutropenia will suffer from febrile without&#xD;
      prophylactic antibiotics. IDSA recommended fluoroquinolones as prophylaxis in neutropenia&#xD;
      patients of high risks, while in China, major pathogens possess high resistance to&#xD;
      fluoroquinolones. It is not clear whether prophylaxis is of benefit, nor the appropriate&#xD;
      prophylaxis regimen.&#xD;
&#xD;
      The current study will evaluate the three different regimen:&#xD;
&#xD;
        1. No prophylaxic antibiotic&#xD;
&#xD;
        2. Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas&#xD;
           activity.&#xD;
&#xD;
        3. Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam&#xD;
           has highest susceptibility rate among common anti-pseudomonas antibiotics.&#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 neutropenia patients into 3 groups.&#xD;
&#xD;
        3. Receive 3 regimen.&#xD;
&#xD;
        4. Full record of clinical data, including background diseases, previous antibiotics within&#xD;
           90 days, febrile or not at the TOC.&#xD;
&#xD;
        5. For patients developed febrile, imipenem will be prescribed, even if the patient&#xD;
           received no prophylaxis. At the same time, the follow-up ended.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">September 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>febrile rate</measure>
    <time_frame>3 weeks after beginning of prophylaxis</time_frame>
    <description>In both group, how many patients developed febrile.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microbiologic efficacy in febrile patients</measure>
    <time_frame>3 weeks after beginning of prophylaxis</time_frame>
    <description>The success rate and failure rate will be calculated.&#xD;
The microbiologic culture is positive at 3 weeks of prophylaxis, showing pathogen sensitive to Piperacillin/tazobactam, the case will be evaluated as breakthrough infection, that means microbiologic failure.&#xD;
The microbiologic culture is negative at 3 weeks of prophylaxis,, or positive fungus or non-typical organisms, the case will be evaluated as microbiologic success.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery rate from neutropenia</measure>
    <time_frame>3 weeks after beginning of prophylaxis</time_frame>
    <description>How many patients reached the ANC &gt; 0.5×109/L more than 3 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE</measure>
    <time_frame>3 weeks after beginning of prophylaxis</time_frame>
    <description>How many patients developed unexpected medical events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of drug and hospital-stay</measure>
    <time_frame>3 weeks after beginning of prophylaxis</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Neutropenia</condition>
  <condition>Hematopoietic Stem Cell Transplantation</condition>
  <arm_group>
    <arm_group_label>No prophylaxis</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>piperacillin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>piperacillin/tazobactam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Piperacillin</intervention_name>
    <description>4.0g q8h 3-5 days</description>
    <arm_group_label>piperacillin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Piperacillin-tazobactam combination product</intervention_name>
    <description>4.5g q8h 3-5 days</description>
    <arm_group_label>piperacillin/tazobactam</arm_group_label>
    <other_name>Tazocin</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>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Wenrong Huang, Doctor</last_name>
      <email>huangwr301@yahoo.com.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</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>October 25, 2012</last_update_submitted>
  <last_update_submitted_qc>October 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2012</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>
  </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>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/NCT01714557
org study id: TZP-HEM-20120608
nct id: NCT01714557
lead sponsor: 
has dmc: No
Neutropenia is very common in patients received hematopoietic stem cell transplantation, with
      median duration of about 14 days. Almost all neutropenia will suffer from febrile without
      prophylactic antibiotics. IDSA recommended fluoroquinolones as prophylaxis in neutropenia
      patients of high risks, while in China, major pathogens possess high resistance to
      fluoroquinolones. It is not clear whether prophylaxis is of benefit, nor the appropriate
      prophylaxis regimen.

      The current study will evaluate the three different regimen:

        1. No prophylaxic antibiotic

        2. Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas
           activity.

        3. Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam
           has highest susceptibility rate among common anti-pseudomonas antibiotics.
1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room
           after transplantation.

        2. Randomize the neutropenia patients into 3 groups.

        3. Receive 3 regimen.

        4. Full record of clinical data, including background diseases, previous antibiotics within
           90 days, febrile or not at the TOC.

        5. For patients developed febrile, imipenem will be prescribed, even if the patient
           received no prophylaxis. At the same time, the follow-up ended.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: febrile rate
time frame: 3 weeks after beginning of prophylaxis
description: In both group, how many patients developed febrile.
measure: Microbiologic efficacy in febrile patients
time frame: 3 weeks after beginning of prophylaxis
description: The success rate and failure rate will be calculated.
The microbiologic culture is positive at 3 weeks of prophylaxis, showing pathogen sensitive to Piperacillin/tazobactam, the case will be evaluated as breakthrough infection, that means microbiologic failure.
The microbiologic culture is negative at 3 weeks of prophylaxis,, or positive fungus or non-typical organisms, the case will be evaluated as microbiologic success.
measure: Recovery rate from neutropenia
time frame: 3 weeks after beginning of prophylaxis
description: How many patients reached the ANC > 0.5×109/L more than 3 days.
measure: AE
time frame: 3 weeks after beginning of prophylaxis
description: How many patients developed unexpected medical events.
measure: Cost of drug and hospital-stay
time frame: 3 weeks after beginning of prophylaxis
arm group label: No prophylaxis
arm group type: No Intervention
arm group label: piperacillin
arm group type: Active Comparator
arm group label: piperacillin/tazobactam
arm group type: Experimental
intervention type: Drug
intervention name: Piperacillin
description: 4.0g q8h 3-5 days
arm group label: piperacillin
intervention type: Drug
intervention name: Piperacillin-tazobactam combination product
description: 4.5g q8h 3-5 days
arm group label: piperacillin/tazobactam
other name: Tazocin
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: 
contact: 
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: Tazobactam
mesh term: Piperacillin
mesh term: Piperacillin, Tazobactam Drug Combination