<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/NCT03229135</url>
  </required_header>
  <id_info>
    <org_study_id>LZhou</org_study_id>
    <nct_id>NCT03229135</nct_id>
  </id_info>
  <brief_title>Loading Regimen，Serum Trough Concentrations，Efficacy and Safety in Pneumonia Patients With Gram-positive Infections</brief_title>
  <official_title>A Retrospective Study of Relationships Between Loading Regimen，Serum Trough Concentrations，Efficacy and Safety in Pneumonia Patients With Gram-positive Infections Treated With Teicoplanin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>People's Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>People's Hospital of Zhengzhou University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a retrospective study that all teicoplanin-treated adult patients with Gram-positive&#xD;
      infections admitted to Zhengzhou Central Hospital affiliated to Zhengzhou University from&#xD;
      February 2015 to August 2016.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Patients and protocol This was a retrospective study that all teicoplanin-treated adult&#xD;
           patients with Gram-positive infections admitted to Zhengzhou Central Hospital affiliated&#xD;
           to Zhengzhou University from February 2015 to August 2016. Patients were included who&#xD;
           met the following criteria: (1) age≥18 years, (2) duration of teicoplanin therapy≥5&#xD;
           days, (3) written informed consent was obtained from each patients. Patients were&#xD;
           excluded who fulfilled any of the following criteria: (1) Patients who were allergy to&#xD;
           teicoplanin, (2) pregnant women, (3) patients with hematopoietic function, (4) patients&#xD;
           unable to evaluate efficacy and safety. This study was approved by the research ethics&#xD;
           committee of the Zhengzhou Central Hospital affiliated to Zhengzhou University.&#xD;
&#xD;
        2. Treatment regimen and groups According to CLcr and teicoplanin loading dose regimen, all&#xD;
           patients were divided into four groups. Group A (CLcr≥60mL/min) : Teicoplanin was&#xD;
           intravenously administered 3 times for moderate infections (skin, soft tissue and&#xD;
           respiratory infections) or 6 times for severe infections(endocarditis caused by MRSA or&#xD;
           severe pneumonia) at the loading dose of 400 mg at 12h intervals, followed by&#xD;
           maintenance dosing 400 mg/d. Group B (40 mL/min≤CLcr&lt;60mL/min) : Teicoplanin was&#xD;
           intravenously administered 3 times at the loading dose of 400 mg at 12h intervals,&#xD;
           followed by maintenance dosing 400 mg/d. Group C (CLcr&lt;40mL/min) : Teicoplanin was&#xD;
           intravenously administered 2 times at the loading dose of 400 mg at 12h intervals,&#xD;
           followed by maintenance dosing 200 mg/d. Group D (standard regimen) : Teicoplanin was&#xD;
           intravenously administered 1-3 times at the loading dose of 400 mg at 12h intervals,&#xD;
           followed by maintenance dosing 200 mg/d. The maintenance dosing was adjusted by Cmin and&#xD;
           CLcr in all groups. The target Cmin was set to 15~30 mg/L. If Cmin&lt;15 mg/L or &gt;30 mg/L,&#xD;
           the maintenance dosage was increased or decreased appropriately up to target Cmin range.&#xD;
           CLcr values for male and female were calculated based on the following equations,&#xD;
           respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2015</start_date>
  <completion_date type="Actual">October 30, 2016</completion_date>
  <primary_completion_date type="Actual">August 20, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum teicoplanin trough concentrations</measure>
    <time_frame>0.5 hour before teicoplanin administration on the fourth day</time_frame>
    <description>Teicoplanin trough samples were taken immediately 30 minutes before teicoplanin administration on the fourth day. Blood samples for 2-3 mL were collected in blood-collection tubes without any additives and centrifuged at 3500 rpm for 10min. Serum teicoplanin trough concentrations (Cmin) were determined by a high-performance liquid chromatography method as previously described. The detections were completed in Translational Medicine Center of Zhengzhou Central Hospital affiliated to Zhengzhou University.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>White blood cell count (WBC)</measure>
    <time_frame>2 years</time_frame>
    <description>It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reaction protein (CRP)</measure>
    <time_frame>2 years</time_frame>
    <description>It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asparttate aminotransferase (AST)</measure>
    <time_frame>2 years</time_frame>
    <description>It is an indicator of liver function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine aminotransferase (ALT)</measure>
    <time_frame>2 years</time_frame>
    <description>It is an indicator of liver function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum creatinine (Scr)</measure>
    <time_frame>2 years</time_frame>
    <description>It is an indicator of renal function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLcr</measure>
    <time_frame>2 years</time_frame>
    <description>It is an indicator of renal function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">113</enrollment>
  <condition>Pneumonia Gram-Positive Bacterial</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Group A (CLcr≥60mL/min) : Teicoplanin was intravenously administered 3 times for moderate infections (skin, soft tissue and respiratory infections) or 6 times for severe infections(endocarditis caused by MRSA or severe pneumonia) at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>Group B (40 mL/min≤CLcr&lt;60mL/min) : Teicoplanin was intravenously administered 3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <description>Group C (CLcr&lt;40mL/min) : Teicoplanin was intravenously administered 2 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <description>Group D (standard regimen) : Teicoplanin was intravenously administered 1-3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>other antibacterial agents，breathing machine</intervention_name>
    <description>If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents. Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The clinical data of 113 patients who were suffered with severe Gram-positive infection and&#xD;
        treated with teicoplanin from February 2015 to August 2016 were retrospectively analyzed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age≥18 years&#xD;
&#xD;
          -  duration of teicoplanin therapy≥5 days&#xD;
&#xD;
          -  written informed consent was obtained from each patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who were allergy to teicoplanin&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  patients with hematopoietic function&#xD;
&#xD;
          -  patients unable to evaluate efficacy and safety&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>People's Hospital of Zhengzhou University</investigator_affiliation>
    <investigator_full_name>LIjuan Zhou</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</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/NCT03229135
org study id: LZhou
nct id: NCT03229135
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This was a retrospective study that all teicoplanin-treated adult patients with Gram-positive
      infections admitted to Zhengzhou Central Hospital affiliated to Zhengzhou University from
      February 2015 to August 2016.
1. Patients and protocol This was a retrospective study that all teicoplanin-treated adult
           patients with Gram-positive infections admitted to Zhengzhou Central Hospital affiliated
           to Zhengzhou University from February 2015 to August 2016. Patients were included who
           met the following criteria: (1) age≥18 years, (2) duration of teicoplanin therapy≥5
           days, (3) written informed consent was obtained from each patients. Patients were
           excluded who fulfilled any of the following criteria: (1) Patients who were allergy to
           teicoplanin, (2) pregnant women, (3) patients with hematopoietic function, (4) patients
           unable to evaluate efficacy and safety. This study was approved by the research ethics
           committee of the Zhengzhou Central Hospital affiliated to Zhengzhou University.

        2. Treatment regimen and groups According to CLcr and teicoplanin loading dose regimen, all
           patients were divided into four groups. Group A (CLcr≥60mL/min) : Teicoplanin was
           intravenously administered 3 times for moderate infections (skin, soft tissue and
           respiratory infections) or 6 times for severe infections(endocarditis caused by MRSA or
           severe pneumonia) at the loading dose of 400 mg at 12h intervals, followed by
           maintenance dosing 400 mg/d. Group B (40 mL/min≤CLcr<60mL/min) : Teicoplanin was
           intravenously administered 3 times at the loading dose of 400 mg at 12h intervals,
           followed by maintenance dosing 400 mg/d. Group C (CLcr<40mL/min) : Teicoplanin was
           intravenously administered 2 times at the loading dose of 400 mg at 12h intervals,
           followed by maintenance dosing 200 mg/d. Group D (standard regimen) : Teicoplanin was
           intravenously administered 1-3 times at the loading dose of 400 mg at 12h intervals,
           followed by maintenance dosing 200 mg/d. The maintenance dosing was adjusted by Cmin and
           CLcr in all groups. The target Cmin was set to 15~30 mg/L. If Cmin<15 mg/L or >30 mg/L,
           the maintenance dosage was increased or decreased appropriately up to target Cmin range.
           CLcr values for male and female were calculated based on the following equations,
           respectively.
observational model: Case-Control
time perspective: Retrospective
measure: Serum teicoplanin trough concentrations
time frame: 0.5 hour before teicoplanin administration on the fourth day
description: Teicoplanin trough samples were taken immediately 30 minutes before teicoplanin administration on the fourth day. Blood samples for 2-3 mL were collected in blood-collection tubes without any additives and centrifuged at 3500 rpm for 10min. Serum teicoplanin trough concentrations (Cmin) were determined by a high-performance liquid chromatography method as previously described. The detections were completed in Translational Medicine Center of Zhengzhou Central Hospital affiliated to Zhengzhou University.
measure: White blood cell count (WBC)
time frame: 2 years
description: It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
measure: C-reaction protein (CRP)
time frame: 2 years
description: It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
measure: Asparttate aminotransferase (AST)
time frame: 2 years
description: It is an indicator of liver function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
measure: Alanine aminotransferase (ALT)
time frame: 2 years
description: It is an indicator of liver function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
measure: Serum creatinine (Scr)
time frame: 2 years
description: It is an indicator of renal function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
measure: CLcr
time frame: 2 years
description: It is an indicator of renal function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
arm group label: Group A
description: Group A (CLcr≥60mL/min) : Teicoplanin was intravenously administered 3 times for moderate infections (skin, soft tissue and respiratory infections) or 6 times for severe infections(endocarditis caused by MRSA or severe pneumonia) at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d.
arm group label: Group B
description: Group B (40 mL/min≤CLcr<60mL/min) : Teicoplanin was intravenously administered 3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d.
arm group label: Group C
description: Group C (CLcr<40mL/min) : Teicoplanin was intravenously administered 2 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d.
arm group label: Group D
description: Group D (standard regimen) : Teicoplanin was intravenously administered 1-3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d.
intervention type: Device
intervention name: other antibacterial agents，breathing machine
description: If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents. Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: People's Hospital of Zhengzhou University
investigator full name: LIjuan Zhou
investigator title: Principal Investigator
mesh term: Pneumonia
mesh term: Anti-Bacterial Agents
sharing ipd: No