<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/NCT03020901</url>
  </required_header>
  <id_info>
    <org_study_id>FM-P5-2016052501</org_study_id>
    <nct_id>NCT03020901</nct_id>
  </id_info>
  <brief_title>the Clinical Trial of Teicoplanin for Injection</brief_title>
  <official_title>100000cases Real World Research of the Safety, Efficacy Reassessment, and Bacterial Resistance Monitoring of Teicoplanin for Injection After Listing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Famous Medical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu Famous Medical Technology Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Primary study endpoint Security Effectiveness&#xD;
&#xD;
        2. Secondary study endpoint Extensive use of population characteristics Clinical drug&#xD;
           characteristics appropriate crowd characteristics Adverse reactions susceptible&#xD;
           population characteristics Reveal rare, new, unanticipated and long-term adverse drug&#xD;
           reactions bacterial resistance Explore the advantages of teicoplanin in combination with&#xD;
           other antimicrobial agents Explore the opportunistic use of teicoplanin for injection&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research purposes&#xD;
&#xD;
        1. To explore the safety and efficacy of different doses of teicoplanin for injection in&#xD;
           the real world&#xD;
&#xD;
        2. To explore the characteristics of different doses of teicoplanin for injection, the&#xD;
           clinical characteristics of drug use and repeated use of bacterial resistance;&#xD;
&#xD;
        3. Reveal rare or even very rare, new, unanticipated, and adverse drug reactions associated&#xD;
           with long-term use;&#xD;
&#xD;
        4. To explore the advantages of different doses of teicoplanin in combination with other&#xD;
           antimicrobial agents;&#xD;
&#xD;
        5. To explore the use of teicoplanin in the treatment of infectious diseases on the&#xD;
           rational use of drugs time;&#xD;
&#xD;
        6. To reveal the risk factors of adverse reactions and susceptibility to people, to&#xD;
           identify the characteristics of the crowd;&#xD;
&#xD;
        7. To investigate the clinical use of teicoplanin injection for the real situation, for&#xD;
           further risk management, to expand the indications and expert consensus dose study to&#xD;
           provide clinical clues and basis;&#xD;
&#xD;
        8. To provide reference for revision of clinical guidelines and consensus, clinical pathway&#xD;
           design;&#xD;
&#xD;
        9. To further enhance the level of safe use of teicoplanin injection, basic medical support&#xD;
           and market vitality.&#xD;
&#xD;
      Research design&#xD;
&#xD;
        1. National, large-scale, standardized, standardized, real-world research;&#xD;
&#xD;
        2. Prospective, single - arm open, non - interventional, registration, multi - center&#xD;
           clinical study;&#xD;
&#xD;
        3. In the hospitals using teicoplanin for injection, 200 were selected on the basis of&#xD;
           voluntary principles;&#xD;
&#xD;
        4. Registration of teicoplanin in patients with injection;&#xD;
&#xD;
        5. Target sample size of 100,000 cases;&#xD;
&#xD;
        6. Exemption from informed consent for ethical review applications;&#xD;
&#xD;
        7. Study of teicoplanin and large-scale data on the safety and effectiveness of&#xD;
           antibiotics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Bacterial clearance rate</measure>
    <time_frame>1-21 days after injection</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">100000</enrollment>
  <condition>Infectious Disease</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teicoplanin for Injection</intervention_name>
    <description>Use Teicoplanin for Injection</description>
    <other_name>Ta Ge Shi</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Prescription for teicoplanin in patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prescription for teicoplanin in patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NO&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yingchun Xu, Doctor</last_name>
    <phone>13911303028</phone>
    <email>xycpumch@139.com</email>
  </overall_contact>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</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>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Teicoplanin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03020901
org study id: FM-P5-2016052501
nct id: NCT03020901
lead sponsor: 
has dmc: No
1. Primary study endpoint Security Effectiveness

        2. Secondary study endpoint Extensive use of population characteristics Clinical drug
           characteristics appropriate crowd characteristics Adverse reactions susceptible
           population characteristics Reveal rare, new, unanticipated and long-term adverse drug
           reactions bacterial resistance Explore the advantages of teicoplanin in combination with
           other antimicrobial agents Explore the opportunistic use of teicoplanin for injection
Research purposes

        1. To explore the safety and efficacy of different doses of teicoplanin for injection in
           the real world

        2. To explore the characteristics of different doses of teicoplanin for injection, the
           clinical characteristics of drug use and repeated use of bacterial resistance;

        3. Reveal rare or even very rare, new, unanticipated, and adverse drug reactions associated
           with long-term use;

        4. To explore the advantages of different doses of teicoplanin in combination with other
           antimicrobial agents;

        5. To explore the use of teicoplanin in the treatment of infectious diseases on the
           rational use of drugs time;

        6. To reveal the risk factors of adverse reactions and susceptibility to people, to
           identify the characteristics of the crowd;

        7. To investigate the clinical use of teicoplanin injection for the real situation, for
           further risk management, to expand the indications and expert consensus dose study to
           provide clinical clues and basis;

        8. To provide reference for revision of clinical guidelines and consensus, clinical pathway
           design;

        9. To further enhance the level of safe use of teicoplanin injection, basic medical support
           and market vitality.

      Research design

        1. National, large-scale, standardized, standardized, real-world research;

        2. Prospective, single - arm open, non - interventional, registration, multi - center
           clinical study;

        3. In the hospitals using teicoplanin for injection, 200 were selected on the basis of
           voluntary principles;

        4. Registration of teicoplanin in patients with injection;

        5. Target sample size of 100,000 cases;

        6. Exemption from informed consent for ethical review applications;

        7. Study of teicoplanin and large-scale data on the safety and effectiveness of
           antibiotics.
observational model: Case-Only
time perspective: Retrospective
measure: Bacterial clearance rate
time frame: 1-21 days after injection
intervention type: Drug
intervention name: Teicoplanin for Injection
description: Use Teicoplanin for Injection
other name: Ta Ge Shi
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yingchun Xu, Doctor
phone: 13911303028
email: xycpumch@139.com
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Teicoplanin
sharing ipd: Undecided