<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/NCT03020940</url>
  </required_header>
  <id_info>
    <org_study_id>FM-P5-2016072201-1</org_study_id>
    <nct_id>NCT03020940</nct_id>
  </id_info>
  <brief_title>The Clinical Trial of Cefuroxime Axetil Dispersible Tablets</brief_title>
  <official_title>100000 Cases Real World Research of the Safety and Efficacy Revaluation of Cefuroxime Axetil Dispersible Tablets 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. 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 use of cefuroxime axetil dispersible tablets in the hospital, according to the&#xD;
           principle of voluntary selection of 200;&#xD;
&#xD;
        4. registration of the use of cefuroxime axetil dispersion tablets patients;&#xD;
&#xD;
        5. Target sample size of 100,000 cases;&#xD;
&#xD;
        6. Exemption from informed consent for ethical review applications;&#xD;
&#xD;
        7. Antibiotic drug safety re-evaluation of large data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research purposes&#xD;
&#xD;
        1. To evaluate the safety of cefuroxime axetil dispersible tablets in the real world of the&#xD;
           widely used population,&#xD;
&#xD;
           Rare or even very rare, new, unanticipated adverse reactions, while revealing adverse&#xD;
           reactions&#xD;
&#xD;
           Should be susceptible to risk factors and susceptible populations.&#xD;
&#xD;
        2. To evaluate the efficacy of cefuroxime axetil dispersible tablets in the treatment of&#xD;
           the relevant site of infection, including&#xD;
&#xD;
           Including empirical therapy and targeted therapy, to further evaluate the widespread use&#xD;
           of cefuroxime dispersible tablets&#xD;
&#xD;
           The validity of the crowd in the real world.&#xD;
&#xD;
        3. To investigate the clinical application of cefuroxime axetil dispersible tablets for the&#xD;
           safety management of drug use.&#xD;
&#xD;
           Clinical management should provide more clinical clues and basis.&#xD;
&#xD;
        4. For the relevant treatment areas of guidance and consensus revision, clinical pathway&#xD;
           design provides a reference.&#xD;
&#xD;
        5. To further improve the safety of cefuroxime axetil dispersion tablets level, the basic&#xD;
           medical security capabilities and Market vitality.&#xD;
&#xD;
      Study end point&#xD;
&#xD;
        1. The main study endpoint:&#xD;
&#xD;
             -  Security;&#xD;
&#xD;
             -  Effectiveness.&#xD;
&#xD;
        2. Secondary study endpoint:&#xD;
&#xD;
             -  Extensive use of population characteristics;&#xD;
&#xD;
             -  Clinical drug characteristics;&#xD;
&#xD;
             -  Appropriate characteristics of the crowd;&#xD;
&#xD;
             -  Adverse reactions susceptible population characteristics.&#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">November 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</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</measure>
    <time_frame>1 to 14 days after the use of Cefuroxime Axetil Dispersible Tablets，</time_frame>
    <description>1.clear 2.Assume purge 3.Not cleared 4.Assume not cleared 5.Partially cleared 6.replace 7.Re-infection 8.Colonization 9.Can not be evaluated</description>
  </primary_outcome>
  <enrollment type="Anticipated">100000</enrollment>
  <condition>Infectious Disease</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefuroxime Axetil Dispersible Tablets</intervention_name>
    <description>Oral. This product can be taken orally, can also be added to the amount of warm water after mixing evenly.&#xD;
Adult general 0.25g (one time), 2 times a day, the general course of treatment for 5 to 10 days.&#xD;
Severe Infection or suspected pneumonia, a 0.5g (once 2), 2 times a day; general urinary tract infection, a Times a 0.125g (one and a half tablets), 2 times a day; for patients with no complications of gonorrhea recommended dose of 1g (4 Tablets), a single taking.&#xD;
Children generally a dose of 0.125g (one-half tablets), 2 times a day; for less than two years of age in the middle ear Inflammatory patients, a 0.125g (one half tablets), 2 times a day; for greater than two years of otitis media patients, one Times a 0.25g (one time), 2 times a day; more than 12 years of age in children, the same dose for adults</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Prescription of cefuroxime axetil dispersible tablets in patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prescription of cefuroxime axetil dispersible tablets 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>Xiaojun Ma, doctor</last_name>
    <phone>13911378823</phone>
    <email>drmaxiaojun@sina.com</email>
  </overall_contact>
  <verification_date>August 2016</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>Cefuroxime</mesh_term>
    <mesh_term>Cefuroxime axetil</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/NCT03020940
org study id: FM-P5-2016072201-1
nct id: NCT03020940
lead sponsor: 
has dmc: No
1. National, large-scale, standardized, standardized, real-world research;

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

        3. in the use of cefuroxime axetil dispersible tablets in the hospital, according to the
           principle of voluntary selection of 200;

        4. registration of the use of cefuroxime axetil dispersion tablets patients;

        5. Target sample size of 100,000 cases;

        6. Exemption from informed consent for ethical review applications;

        7. Antibiotic drug safety re-evaluation of large data.
Research purposes

        1. To evaluate the safety of cefuroxime axetil dispersible tablets in the real world of the
           widely used population,

           Rare or even very rare, new, unanticipated adverse reactions, while revealing adverse
           reactions

           Should be susceptible to risk factors and susceptible populations.

        2. To evaluate the efficacy of cefuroxime axetil dispersible tablets in the treatment of
           the relevant site of infection, including

           Including empirical therapy and targeted therapy, to further evaluate the widespread use
           of cefuroxime dispersible tablets

           The validity of the crowd in the real world.

        3. To investigate the clinical application of cefuroxime axetil dispersible tablets for the
           safety management of drug use.

           Clinical management should provide more clinical clues and basis.

        4. For the relevant treatment areas of guidance and consensus revision, clinical pathway
           design provides a reference.

        5. To further improve the safety of cefuroxime axetil dispersion tablets level, the basic
           medical security capabilities and Market vitality.

      Study end point

        1. The main study endpoint:

             -  Security;

             -  Effectiveness.

        2. Secondary study endpoint:

             -  Extensive use of population characteristics;

             -  Clinical drug characteristics;

             -  Appropriate characteristics of the crowd;

             -  Adverse reactions susceptible population characteristics.
observational model: Case-Only
time perspective: Retrospective
measure: Bacterial clearance
time frame: 1 to 14 days after the use of Cefuroxime Axetil Dispersible Tablets，
description: 1.clear 2.Assume purge 3.Not cleared 4.Assume not cleared 5.Partially cleared 6.replace 7.Re-infection 8.Colonization 9.Can not be evaluated
intervention type: Drug
intervention name: Cefuroxime Axetil Dispersible Tablets
description: Oral. This product can be taken orally, can also be added to the amount of warm water after mixing evenly.
Adult general 0.25g (one time), 2 times a day, the general course of treatment for 5 to 10 days.
Severe Infection or suspected pneumonia, a 0.5g (once 2), 2 times a day; general urinary tract infection, a Times a 0.125g (one and a half tablets), 2 times a day; for patients with no complications of gonorrhea recommended dose of 1g (4 Tablets), a single taking.
Children generally a dose of 0.125g (one-half tablets), 2 times a day; for less than two years of age in the middle ear Inflammatory patients, a 0.125g (one half tablets), 2 times a day; for greater than two years of otitis media patients, one Times a 0.25g (one time), 2 times a day; more than 12 years of age in children, the same dose for adults
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Xiaojun Ma, doctor
phone: 13911378823
email: drmaxiaojun@sina.com
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Cefuroxime
mesh term: Cefuroxime axetil
sharing ipd: Undecided