<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/NCT03776409</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AF2018LSK-169</org_study_id>
    <nct_id>NCT03776409</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Vancomycin Plus Beta-lactams</brief_title>
  <acronym>SEVPB</acronym>
  <official_title>Comparison of the Nephrotoxicity of Vancomycin in Combination With Piperacillin/Tazobactam or Other Beta-lactams in Critically Ill Patients: A Retrospective, Multicenter Study in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Second Affiliated Hospital of Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The combination of vancomycin and piperacillin-tazobactam has been associated with an&#xD;
      increased risk of acute kidney injury (AKI) in non-critically ill patient populations, but it&#xD;
      is still unknown if this association exists in critically ill patients. The objective of this&#xD;
      study is to compare AKI and efficacy of vancomycin plus piperacillin-tazobactam or&#xD;
      beta-lactams.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The combination of vancomycin and piperacillin-tazobactam has been associated with an&#xD;
      increased risk of acute kidney injury (AKI) in non-critically ill patient populations, but&#xD;
      limited data regarding this association exists in critically ill patients. The objective of&#xD;
      this study is to compare AKI and efficacy of vancomycin plus piperacillin-tazobactam or&#xD;
      beta-lactams.&#xD;
&#xD;
      This is a multicenter, retrospective cohort study. Patients from the retrospective cohort&#xD;
      will be divided into 2 groups based on the combination regimen received . Patients who meet&#xD;
      the inclusion and exclusion criteria will be included in our registry. As a non-intervention&#xD;
      study, these information as below will be collected: basic demographics, diagnosis,&#xD;
      concomitant nephrotoxic and other antibiotic medications, serum creatine levels, vancomycin&#xD;
      concentrations, and indication for antibiotics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>AKI(acute kidney injury)</measure>
    <time_frame>from 24 hours after the start of the combination until discharge up to one month</time_frame>
    <description>the incidence of acute kidney injury</description>
  </primary_outcome>
  <primary_outcome>
    <measure>clinical efficacy</measure>
    <time_frame>from 24 hours after the start of the combination until discharge up to one month</time_frame>
    <description>microbial eradication</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the length of hospital stay</measure>
    <time_frame>from hospital admission to discharge up to one month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of AKI</measure>
    <time_frame>the time from AKI onset to resolution of AKI up to one month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>onset of AKI</measure>
    <time_frame>the first occurence of AKI after starting concomitant antimicrobial use up to one month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>whether renal function return to baseline or not</measure>
    <time_frame>from AKI onset to resolution of defined AKI up to one month</time_frame>
    <description>whether defined AKI was resoluted or not</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>major acute kidney events at 30 days (MAKE30)</measure>
    <time_frame>MAKE30 is assessed 30 days following AKI diagnosis</time_frame>
    <description>MAKE30 is assessed 30 days following AKI diagnosis, which is a composite outcome of death, new dialysis, and worsened renal function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vancomycin trough value assessment</measure>
    <time_frame>from hospital admission to discharge up to one month</time_frame>
    <description>assess the impact of vancomycin exposures on development of AKI</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">700</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>vancomycin plus piperacillin/tazobactam</arm_group_label>
    <description>Critically ill patients who received the combination of VAN (vancomycin) and PTZ (piperacillin/tazobactam) for at least 48 hours during an ICU (intensive care unit) admission, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and PTZ were adjusted based on clinical practice and patient characteristics. This is an observational study without any intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vancomycin plus other beta-lactams</arm_group_label>
    <description>Critically ill patients who received the combination of VAN (vancomycin) and other beta-lactams (cefoperazone/sulbactam, meropenem, imipenem/siastatin, ceftriaxone, ceftazidime, et al) for at least 48 hours during an ICU (intensive care unit) admission, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and other beta-lactams were adjusted based on clinical practice and patient characteristics. This is an observational study without any intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>vancomycin plus piperacillin/tazobactam</intervention_name>
    <description>Patients in intensive care unit who received the combination of VAN(vancomycin) and PTZ (piperacillin/tazobactam) for at least 48 hours, had a serum creatinine level measured in the 24-hour of hospital admission.The dosage and frequency of VAN and PTZ was adjusted based on clinical practice and patient characteristics.</description>
    <arm_group_label>vancomycin plus piperacillin/tazobactam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>vancomycin plus other beta-lactams</intervention_name>
    <description>Patients in intensive care unit who received the combination of VAN (vancomycin) and other beta-lactams (cefoperazone/sulbactam, meropenem, imipenem/siastatin, ceftriaxone, ceftazidime, et al) for at least 48 hours, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and other beta-lactams were adjusted based on clinical practice and patient characteristics.</description>
    <arm_group_label>vancomycin plus other beta-lactams</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        critically ill patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older,&#xD;
&#xD;
          -  admitted to intensive care unit&#xD;
&#xD;
          -  received the combination of vancomycin and beta-lactams for at least 48 hours&#xD;
&#xD;
          -  had a serum creatinine level measured within 24-hour hospital admission&#xD;
&#xD;
          -  had at least one VAN level drawn while receiving a combination of study antibiotics&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy or lactating patients&#xD;
&#xD;
          -  admission to the intensive care unit during administration or within 72 hours of&#xD;
             completing the antibiotics&#xD;
&#xD;
          -  had end-stage renal disease&#xD;
&#xD;
          -  died within 48 hours of combination antibiotic therapy initiation&#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>Yalin Dong, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Xian Jiaotong University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>First Affiliated Hospital of Xian Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>June 21, 2020</last_update_submitted>
  <last_update_submitted_qc>June 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vancomycin</mesh_term>
    <mesh_term>Tazobactam</mesh_term>
    <mesh_term>Piperacillin</mesh_term>
    <mesh_term>Piperacillin, Tazobactam Drug Combination</mesh_term>
    <mesh_term>Lactams</mesh_term>
    <mesh_term>beta-Lactams</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03776409
org study id: XJTU1AF2018LSK-169
nct id: NCT03776409
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The combination of vancomycin and piperacillin-tazobactam has been associated with an
      increased risk of acute kidney injury (AKI) in non-critically ill patient populations, but it
      is still unknown if this association exists in critically ill patients. The objective of this
      study is to compare AKI and efficacy of vancomycin plus piperacillin-tazobactam or
      beta-lactams.
The combination of vancomycin and piperacillin-tazobactam has been associated with an
      increased risk of acute kidney injury (AKI) in non-critically ill patient populations, but
      limited data regarding this association exists in critically ill patients. The objective of
      this study is to compare AKI and efficacy of vancomycin plus piperacillin-tazobactam or
      beta-lactams.

      This is a multicenter, retrospective cohort study. Patients from the retrospective cohort
      will be divided into 2 groups based on the combination regimen received . Patients who meet
      the inclusion and exclusion criteria will be included in our registry. As a non-intervention
      study, these information as below will be collected: basic demographics, diagnosis,
      concomitant nephrotoxic and other antibiotic medications, serum creatine levels, vancomycin
      concentrations, and indication for antibiotics.
observational model: Cohort
time perspective: Retrospective
measure: AKI(acute kidney injury)
time frame: from 24 hours after the start of the combination until discharge up to one month
description: the incidence of acute kidney injury
measure: clinical efficacy
time frame: from 24 hours after the start of the combination until discharge up to one month
description: microbial eradication
measure: the length of hospital stay
time frame: from hospital admission to discharge up to one month
measure: duration of AKI
time frame: the time from AKI onset to resolution of AKI up to one month
measure: onset of AKI
time frame: the first occurence of AKI after starting concomitant antimicrobial use up to one month
measure: whether renal function return to baseline or not
time frame: from AKI onset to resolution of defined AKI up to one month
description: whether defined AKI was resoluted or not
measure: major acute kidney events at 30 days (MAKE30)
time frame: MAKE30 is assessed 30 days following AKI diagnosis
description: MAKE30 is assessed 30 days following AKI diagnosis, which is a composite outcome of death, new dialysis, and worsened renal function.
measure: vancomycin trough value assessment
time frame: from hospital admission to discharge up to one month
description: assess the impact of vancomycin exposures on development of AKI
arm group label: vancomycin plus piperacillin/tazobactam
description: Critically ill patients who received the combination of VAN (vancomycin) and PTZ (piperacillin/tazobactam) for at least 48 hours during an ICU (intensive care unit) admission, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and PTZ were adjusted based on clinical practice and patient characteristics. This is an observational study without any intervention.
arm group label: vancomycin plus other beta-lactams
description: Critically ill patients who received the combination of VAN (vancomycin) and other beta-lactams (cefoperazone/sulbactam, meropenem, imipenem/siastatin, ceftriaxone, ceftazidime, et al) for at least 48 hours during an ICU (intensive care unit) admission, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and other beta-lactams were adjusted based on clinical practice and patient characteristics. This is an observational study without any intervention.
intervention type: Drug
intervention name: vancomycin plus piperacillin/tazobactam
description: Patients in intensive care unit who received the combination of VAN(vancomycin) and PTZ (piperacillin/tazobactam) for at least 48 hours, had a serum creatinine level measured in the 24-hour of hospital admission.The dosage and frequency of VAN and PTZ was adjusted based on clinical practice and patient characteristics.
arm group label: vancomycin plus piperacillin/tazobactam
intervention type: Drug
intervention name: vancomycin plus other beta-lactams
description: Patients in intensive care unit who received the combination of VAN (vancomycin) and other beta-lactams (cefoperazone/sulbactam, meropenem, imipenem/siastatin, ceftriaxone, ceftazidime, et al) for at least 48 hours, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and other beta-lactams were adjusted based on clinical practice and patient characteristics.
arm group label: vancomycin plus other beta-lactams
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yalin Dong, Ph.D
role: Principal Investigator
affiliation: First Affiliated Hospital of Xian Jiaotong University
facility: 
country: China
responsible party type: Sponsor
mesh term: Critical Illness
mesh term: Vancomycin
mesh term: Tazobactam
mesh term: Piperacillin
mesh term: Piperacillin, Tazobactam Drug Combination
mesh term: Lactams
mesh term: beta-Lactams
sharing ipd: No