<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/NCT02191475</url>
  </required_header>
  <id_info>
    <org_study_id>WDH2014</org_study_id>
    <nct_id>NCT02191475</nct_id>
  </id_info>
  <brief_title>Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock</brief_title>
  <acronym>Tigecycline</acronym>
  <official_title>Tigecycline (Hai Zheng Li Xing®) Combined With Piperacillin/Tazobactam (Tazocin ®) Empirical Treatment of Severe Sepsis and Septic Shock in Patients With Abdominal Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zhejiang Hisun Pharmaceutical Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tianjin Medical University Cancer Institute and Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Selection of tigecycline in severe sepsis and septic shock patients in empirical antibiotic&#xD;
      therapy (Hai Zheng Energy Star ®) combined with piperacillin / tazobactam (tazocin ®) scheme,&#xD;
      compared with the classical scheme, evaluate its efficacy, safety index.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tigecycline as representative glycylcycline antibiotics, has wide antibacterial spectrum and&#xD;
      strong antibacterial activity, tigecycline in almost all of the gram positive bacteria and&#xD;
      most gram negative bacteria and atypical pathogens, anaerobic bacteria are very good&#xD;
      antibacterial activity except Pseudomonas aeruginosa, Proteus. Safety on organ function, in&#xD;
      patients with renal insufficiency or in dialysis patients, no dose adjustment is required&#xD;
      application of tigecycline, mild to moderate hepatic insufficiency patients do not need to&#xD;
      adjust the dose of tigecycline. Piperacillin / tazobactam also is a broad spectrum, potent&#xD;
      antibiotics, especially strong bactericidal activity against Pseudomonas aeruginosa,&#xD;
      including resistant enzyme producing gram negative bacilli, in accordance with its&#xD;
      pharmacokinetic pharmacodynamic characteristics of prolonged infusion time can obtain a&#xD;
      stronger bactericidal activity. These two potent drugs have broad antimicrobial spectrum,&#xD;
      strong bactericidal activity, and provide for the treatment of severe sepsis and septic shock&#xD;
      a new choice in antibiotic selection, to a certain extent reduces the resistance pressure,&#xD;
      and have more clinical safety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of treatment between Tigecycline plus tazocin and classic anti infection method</measure>
    <time_frame>2 weeks</time_frame>
    <description>Two groups of patients were assessed anti infection treatment effect per day. Including: temperature, procalcitonin, blood routine, liver and kidney function, bacteriological evidence, hemodynamics&#xD;
Effects of Haizheng Li Xing ® combined with tazocin ® in clinical treatment is not inferior to the classical antibiotics scheme</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Successful rate between two groups with abnormal renal function and liver function abnormalities which should adjust dose of drugs</measure>
    <time_frame>2 weeks</time_frame>
    <description>Evaluation of two groups of patients EGDT treatment compliance rate, mortality rate (the success rate of treatment), ICU stay time.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Residence time and expenses in ICU</measure>
    <time_frame>2 weeks</time_frame>
    <description>Patients with ICU residence time and expenses have no difference between the two groups.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Abdominal Infection</condition>
  <arm_group>
    <arm_group_label>glycopeptide plus carbapenem</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group antibiotic selection according to the classical scheme use of glycopeptide plus carbapenem antibiotic (or oxazolidinone antibiotics), with or without antifungal therapy, dose of imipenem/cilastatin 500mg, IVdrip, 3~4 times/d, or meropenem 1g, IVdrip, 3 times/d; vancomycin for 15mg/kg,2 times/d, or linezolid 300mg, IVdrip, 2 times/d; these drugs are required to state organ function in patients with drug doses adjustment, treatment for 3-5 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Haizheng Li Xing ® plus tazocin ®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tigecycline (Haizheng Li Xing ®) combined with piperacillin / tazobactam (tazocin ®), with or without antifungal therapy, dose of tigecycline first dose 100 mg, 50 mg, every 12 hours, piperacillin / tazobactam 4.5g, ivdrip, 3-4 times a day, each time the infusion of 3 hours, treatment for 3-5 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>glycopeptide plus carbapenem</intervention_name>
    <description>The control group antibiotic selection according to the classical scheme use of glycopeptide plus carbapenem antibiotic (or oxazolidinone antibiotics), with or without antifungal therapy</description>
    <arm_group_label>glycopeptide plus carbapenem</arm_group_label>
    <other_name>The clinical curative effect</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Haizheng Li Xing ® plus tazocin ®</intervention_name>
    <description>Tigecycline (Haizheng Li Xing ®) combined with piperacillin/tazobactam (tazocin ®), with or without antifungal therapy</description>
    <arm_group_label>Haizheng Li Xing ® plus tazocin ®</arm_group_label>
    <other_name>The clinical curative effect</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be consistent with severe sepsis and septic shock diagnosis standards&#xD;
&#xD;
          -  Age above 18 years old, is expected in more than 5 days in ICU&#xD;
&#xD;
          -  APACHEⅡ score&gt;15&#xD;
&#xD;
          -  By the patients themselves or their authorized person agreed to participate in the&#xD;
             clinical trial and signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic to penicillin, or of tigecycline allergic patients&#xD;
&#xD;
          -  Patients with abnormal liver function is severe&#xD;
&#xD;
          -  Be pregnant or lactating women&#xD;
&#xD;
          -  Be not signed the informed consent of patients&#xD;
&#xD;
          -  Any can be expected to increase patient risk or other factors can interfere with the&#xD;
             results of a clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wang Donghao, Chief</last_name>
    <role>Study Chair</role>
    <affiliation>Tianjin Medical University Cancer Institute and Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wang Donghao, chief</last_name>
    <phone>022-23340123</phone>
    <phone_ext>1021</phone_ext>
    <email>donghaow@medmail.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>TianjinCIH</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wang Donghao, Chief</last_name>
      <phone>022-23340123</phone>
      <phone_ext>1021</phone_ext>
      <email>donghaow@medmail.com.cn</email>
    </contact>
    <contact_backup>
      <last_name>Wang Donghao Donghao, Chief</last_name>
      <phone>022-23340123</phone>
      <phone_ext>1021</phone_ext>
      <email>donghaow@medmail.com.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Lv Yang, physician</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Sartelli M, Catena F, Coccolini F, Pinna AD. Antimicrobial management of intra-abdominal infections: literature's guidelines. World J Gastroenterol. 2012 Mar 7;18(9):865-71. doi: 10.3748/wjg.v18.i9.865.</citation>
    <PMID>22408344</PMID>
  </reference>
  <results_reference>
    <citation>Eckmann C, Montravers P, Bassetti M, Bodmann KF, Heizmann WR, Sanchez Garcia M, Guirao X, Capparella MR, Simoneau D, Dupont H. Efficacy of tigecycline for the treatment of complicated intra-abdominal infections in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii25-35. doi: 10.1093/jac/dkt142.</citation>
    <PMID>23772043</PMID>
  </results_reference>
  <results_reference>
    <citation>Hawkey P, Finch R. Tigecycline: in-vitro performance as a predictor of clinical efficacy. Clin Microbiol Infect. 2007 Apr;13(4):354-62. doi: 10.1111/j.1469-0691.2006.01621.x.</citation>
    <PMID>17359318</PMID>
  </results_reference>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>June 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 13, 2014</last_update_submitted>
  <last_update_submitted_qc>July 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sepsis shock</keyword>
  <keyword>Tigecycline</keyword>
  <keyword>Piperacillin / tazobactam</keyword>
  <keyword>Abdominal infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Intraabdominal Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02191475
org study id: WDH2014
nct id: NCT02191475
lead sponsor: 
collaborator: 
has dmc: Yes
Selection of tigecycline in severe sepsis and septic shock patients in empirical antibiotic
      therapy (Hai Zheng Energy Star ®) combined with piperacillin / tazobactam (tazocin ®) scheme,
      compared with the classical scheme, evaluate its efficacy, safety index.
Tigecycline as representative glycylcycline antibiotics, has wide antibacterial spectrum and
      strong antibacterial activity, tigecycline in almost all of the gram positive bacteria and
      most gram negative bacteria and atypical pathogens, anaerobic bacteria are very good
      antibacterial activity except Pseudomonas aeruginosa, Proteus. Safety on organ function, in
      patients with renal insufficiency or in dialysis patients, no dose adjustment is required
      application of tigecycline, mild to moderate hepatic insufficiency patients do not need to
      adjust the dose of tigecycline. Piperacillin / tazobactam also is a broad spectrum, potent
      antibiotics, especially strong bactericidal activity against Pseudomonas aeruginosa,
      including resistant enzyme producing gram negative bacilli, in accordance with its
      pharmacokinetic pharmacodynamic characteristics of prolonged infusion time can obtain a
      stronger bactericidal activity. These two potent drugs have broad antimicrobial spectrum,
      strong bactericidal activity, and provide for the treatment of severe sepsis and septic shock
      a new choice in antibiotic selection, to a certain extent reduces the resistance pressure,
      and have more clinical safety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Efficacy of treatment between Tigecycline plus tazocin and classic anti infection method
time frame: 2 weeks
description: Two groups of patients were assessed anti infection treatment effect per day. Including: temperature, procalcitonin, blood routine, liver and kidney function, bacteriological evidence, hemodynamics
Effects of Haizheng Li Xing ® combined with tazocin ® in clinical treatment is not inferior to the classical antibiotics scheme
measure: Successful rate between two groups with abnormal renal function and liver function abnormalities which should adjust dose of drugs
time frame: 2 weeks
description: Evaluation of two groups of patients EGDT treatment compliance rate, mortality rate (the success rate of treatment), ICU stay time.
measure: Residence time and expenses in ICU
time frame: 2 weeks
description: Patients with ICU residence time and expenses have no difference between the two groups.
arm group label: glycopeptide plus carbapenem
arm group type: Active Comparator
description: The control group antibiotic selection according to the classical scheme use of glycopeptide plus carbapenem antibiotic (or oxazolidinone antibiotics), with or without antifungal therapy, dose of imipenem/cilastatin 500mg, IVdrip, 3~4 times/d, or meropenem 1g, IVdrip, 3 times/d; vancomycin for 15mg/kg,2 times/d, or linezolid 300mg, IVdrip, 2 times/d; these drugs are required to state organ function in patients with drug doses adjustment, treatment for 3-5 days.
arm group label: Haizheng Li Xing ® plus tazocin ®
arm group type: Experimental
description: Tigecycline (Haizheng Li Xing ®) combined with piperacillin / tazobactam (tazocin ®), with or without antifungal therapy, dose of tigecycline first dose 100 mg, 50 mg, every 12 hours, piperacillin / tazobactam 4.5g, ivdrip, 3-4 times a day, each time the infusion of 3 hours, treatment for 3-5 days.
intervention type: Drug
intervention name: glycopeptide plus carbapenem
description: The control group antibiotic selection according to the classical scheme use of glycopeptide plus carbapenem antibiotic (or oxazolidinone antibiotics), with or without antifungal therapy
arm group label: glycopeptide plus carbapenem
other name: The clinical curative effect
intervention type: Drug
intervention name: Haizheng Li Xing ® plus tazocin ®
description: Tigecycline (Haizheng Li Xing ®) combined with piperacillin/tazobactam (tazocin ®), with or without antifungal therapy
arm group label: Haizheng Li Xing ® plus tazocin ®
other name: The clinical curative effect
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Wang Donghao, Chief
role: Study Chair
affiliation: Tianjin Medical University Cancer Institute and Hospital
last name: Wang Donghao, chief
phone: 022-23340123
phone ext: 1021
email: donghaow@medmail.com.cn
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
citation: Sartelli M, Catena F, Coccolini F, Pinna AD. Antimicrobial management of intra-abdominal infections: literature's guidelines. World J Gastroenterol. 2012 Mar 7;18(9):865-71. doi: 10.3748/wjg.v18.i9.865.
PMID: 22408344
citation: Eckmann C, Montravers P, Bassetti M, Bodmann KF, Heizmann WR, Sanchez Garcia M, Guirao X, Capparella MR, Simoneau D, Dupont H. Efficacy of tigecycline for the treatment of complicated intra-abdominal infections in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii25-35. doi: 10.1093/jac/dkt142.
PMID: 23772043
citation: Hawkey P, Finch R. Tigecycline: in-vitro performance as a predictor of clinical efficacy. Clin Microbiol Infect. 2007 Apr;13(4):354-62. doi: 10.1111/j.1469-0691.2006.01621.x.
PMID: 17359318
responsible party type: Sponsor
mesh term: Infections
mesh term: Sepsis
mesh term: Intraabdominal Infections
mesh term: Piperacillin, Tazobactam Drug Combination