<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/NCT02205112</url>
  </required_header>
  <id_info>
    <org_study_id>TG-873870-C-6</org_study_id>
    <nct_id>NCT02205112</nct_id>
  </id_info>
  <brief_title>A Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin in Treating CAP</brief_title>
  <official_title>A Multi-center, Randomized, Double-Blind, Parallel Comparative, Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin Versus Levofloxain in Treating Adult Patients With CAP</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TaiGen Biotechnology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TaiGen Biotechnology Co., Ltd.</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of&#xD;
      intravenous nemonoxacin compared with intravenous moxifloxacin in adult patients with&#xD;
      community-acquired pneumonia (CAP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Community-acquired Pneumonia (CAP) remains a leading cause of death in both developing and&#xD;
      developed countries. In the choice of antibacterial agents used to treat CAP,&#xD;
      fluoroquinolones have received considerable attention because of their wide spectrum of&#xD;
      bactericidal activity. TG-873870 (Nemonoxacin), a non-fluorinated quinolone (NFQ), is a&#xD;
      selective bacterial topoisomerase inhibitor.&#xD;
&#xD;
      This study will evaluate the clinical efficacy, microbiological efficacy and safety of&#xD;
      Intravenous nemonoxacin compared with Intravenous levofloxacin in adult patients with&#xD;
      community-acquired pneumonia.&#xD;
&#xD;
      Besides, the populationpharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after&#xD;
      continuous IV Infusion and the pharmacokinetic (PK)/pharmacodynamic (PD)are to be determined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">May 15, 2017</completion_date>
  <primary_completion_date type="Actual">May 4, 2017</primary_completion_date>
  <phase>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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Per subject clinical cure rate</measure>
    <time_frame>end of treatment and 7 to 14 days after the end of treatment</time_frame>
    <description>The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Per subject microbiological cure rate</measure>
    <time_frame>end of treatment and 7 to 14 days after the end of treatment</time_frame>
    <description>The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Per subject overall cure rate</measure>
    <time_frame>end of treatment and 7 to 14 days after the end of treatment</time_frame>
    <description>Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety evaluation</measure>
    <time_frame>duration of trial</time_frame>
    <description>Incidence and severity of AE and changes in safety parameters from baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">598</enrollment>
  <condition>Community-acquired Pneumonia</condition>
  <arm_group>
    <arm_group_label>Nemonoxacin 500 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nemonoxacin 500mg/250mL, intravenous administration, once daily for 7~14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Levofloxacin 500mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Levofloxacin: 500mg/100mL, intravenous administration, once daily for 7~14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nemonoxacin</intervention_name>
    <arm_group_label>Nemonoxacin 500 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levofloxacin</intervention_name>
    <arm_group_label>Levofloxacin 500mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ages between 18 and 80;&#xD;
&#xD;
          2. Weighs between 40 ~ 100 kg, and BMI ≥ 18 kg/m2;&#xD;
&#xD;
          3. Must have a clinical diagnosis of CAP&#xD;
&#xD;
          4. Chest X-ray and /or CT scan show new or persist/progressive infiltrates&#xD;
&#xD;
          5. Patients with PORT/PSI score II, III or IV.&#xD;
&#xD;
          6. If female, non-lactating and at no risk or pregnancy (post-menopausal or must use&#xD;
             adequate birth control)&#xD;
&#xD;
          7. Male must use a reliable form of contraception.&#xD;
&#xD;
          8. Able to receive an intravenous infusion of the drug&#xD;
&#xD;
          9. Able to provide an adequate sputum and blood samples&#xD;
&#xD;
         10. Able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with PORT/PSI score I or VI.&#xD;
&#xD;
          2. Severe CAP is present if a patient needs invasive mechanical ventilation or requires&#xD;
             vasopressors.&#xD;
&#xD;
          3. Healthcare-associated pneumonia, hospital-acquired pneumonia, or hospitalized within&#xD;
             14 days before enrollment&#xD;
&#xD;
          4. Virus pneumonia, aspiration pneumonia, ventilator associated pneumonia, or&#xD;
             intersstitial lung disease&#xD;
&#xD;
          5. Bronchial bostruction (exclusive of COPD), bronchiectasis, cystic fibrosis, known or&#xD;
             suspected pneumocystis pneumonia, known or suspected tuberculosis, primary empyema&#xD;
             thoracis, lung abscess, known or suspected lung cancer, or lung disease associated&#xD;
             with autoimmune disorders.&#xD;
&#xD;
          6. Medical history of QT prolongation, require the treatment of arrhythmia using class IA&#xD;
             or class III drugs, or NYHA functional class &gt;/= III&#xD;
&#xD;
          7. Clinically significant findings on 12-lead ECG, QTc interval&gt;450ms or potassium is &lt;&#xD;
             3.5 mmol/L or lower limit of normal at Screening&#xD;
&#xD;
          8. Immunocompromising illness, such as HIV infection&#xD;
&#xD;
          9. Fatal progressive disease or neurodegenerative diseases that prevent patients from&#xD;
             effectively clearing pulmonary secretions&#xD;
&#xD;
         10. Have medical history of seizure, alcohol or drug abuse, suicide tendency, or psychosis&#xD;
             that can effect the compliance&#xD;
&#xD;
         11. Have diseases that may affect intravenous infusion.&#xD;
&#xD;
         12. Active hepatitis or decompensated cirrhosis with ascites (Child-Pugh score 10-15/class&#xD;
             C);&#xD;
&#xD;
         13. Renal Insufficiency or creatinine &gt;/= 1.1 ULN within 24 hr before first dose&#xD;
&#xD;
         14. ALT or AST &gt;/= 3x ULN, or BUN &gt;/= 30 mg/dL within 24 hr before first dose&#xD;
&#xD;
         15. Neutrophil &lt; 1000 mm3 within 24 hr before first dose&#xD;
&#xD;
         16. Received systemic antibiotics within 72 hr before first dose&#xD;
&#xD;
         17. Received probenecid within 24 hr before first dose or require the treatment with&#xD;
             probenecid during study&#xD;
&#xD;
         18. Received quinolones or fluoroquinolones within 14 days before first dose&#xD;
&#xD;
         19. Received any investigational drugs within 30 days before first dose&#xD;
&#xD;
         20. Require the treatment with other systemic antibiotics during study&#xD;
&#xD;
         21. Patients who are being or will be on a long-term medication (over 2 weeks) of steroids&#xD;
             (20mg/day)&#xD;
&#xD;
         22. Medical history of hypersensitivity to any quinolone, fluoroquinolone-associated&#xD;
             tendinitis and tendon rupture, or myasthenia gravis&#xD;
&#xD;
         23. Current condition or abnormality that, in the opinion of the investigator, would&#xD;
             compromise the safety of the subject or the quality of the data&#xD;
&#xD;
         24. Participated and received the study medication in previous clinical trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Baotou Central Hospital</name>
      <address>
        <city>Baotou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aerospace Center Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Beijing Anzhen Hospital of Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Beijing Chaoyang Hospital of Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese People's Liberation Army General Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Clinical Pharmacology, Peking University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changsha Central Hospital</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Changsha Hotpital</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daping Hospital</name>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangxi Zhuang Autonomous Region People's Hospital</name>
      <address>
        <city>Guangxi</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guilin Medical School Affiliated Hospital</name>
      <address>
        <city>Guilin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hainan General Hospital</name>
      <address>
        <city>Haikou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affilated Hospital of Inner Mongolia Medical University</name>
      <address>
        <city>Hohhot</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Jilin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Fourth Hospital of Jilin University</name>
      <address>
        <city>Jilin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jinan Central Hospital</name>
      <address>
        <city>Jinan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gansu Provincial People's Hospital</name>
      <address>
        <city>Lanzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangxi Provincial People's Hospital</name>
      <address>
        <city>Nanchang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Subsidiary Hospital of Nanchang Medical College</name>
      <address>
        <city>Nanchang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Nanjing Military Command</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Antibiotics, Huashan Hospital, Fundan University</name>
      <address>
        <city>Shanghai</city>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huadong Hospital Affiliated to Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai East Hospital of Tongji University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Pulmonary Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Shenyang Military</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenzhen People's Hospital</name>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second People's Hospital of Shenzhen</name>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Chengdu Military Region</name>
      <address>
        <city>Sichuan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Center of Medical Sciences of Sichuan University</name>
      <address>
        <city>Sichuan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Hospital of Shanxi Medical University</name>
      <address>
        <city>Taiyuan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuxi People's Hospital</name>
      <address>
        <city>Wuxi</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tangdu Hospital</name>
      <address>
        <city>Xi'an</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affilated Hospital of Xiamen University</name>
      <address>
        <city>Xiamen</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Jiangsu People's Hospital</name>
      <address>
        <city>Yangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital,College of Medicine,Zhejiang University</name>
      <address>
        <city>Zhejiang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changhua Christian Hospital</name>
      <address>
        <city>Chang Hua</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiayi Chang Gung Memorial Hospital</name>
      <address>
        <city>Chiayi City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NTUH Hsin-Chu Branch</name>
      <address>
        <city>Hsinchu</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hualien Tzu Chi Hospital</name>
      <address>
        <city>Hualien City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical University Chung-Ho Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keelung Chang Gung Memorial Hospital</name>
      <address>
        <city>Keelung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>New Taipei City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MacKay Memorial Hospital</name>
      <address>
        <city>New Taipei City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chung Shan Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chi Mei Hospital, Liouying</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Medical University - Shuang Ho Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Medical University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Municipal Wanfang Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tri-Service General Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NTUH Yun-Lin Branch</name>
      <address>
        <city>Yuli</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>October 22, 2021</last_update_submitted>
  <last_update_submitted_qc>October 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intravenous nemonoxacin</keyword>
  <keyword>community-acquired pneumonia</keyword>
  <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>Levofloxacin</mesh_term>
    <mesh_term>Nemonoxacin</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/NCT02205112
org study id: TG-873870-C-6
nct id: NCT02205112
lead sponsor: 
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of
      intravenous nemonoxacin compared with intravenous moxifloxacin in adult patients with
      community-acquired pneumonia (CAP).
Community-acquired Pneumonia (CAP) remains a leading cause of death in both developing and
      developed countries. In the choice of antibacterial agents used to treat CAP,
      fluoroquinolones have received considerable attention because of their wide spectrum of
      bactericidal activity. TG-873870 (Nemonoxacin), a non-fluorinated quinolone (NFQ), is a
      selective bacterial topoisomerase inhibitor.

      This study will evaluate the clinical efficacy, microbiological efficacy and safety of
      Intravenous nemonoxacin compared with Intravenous levofloxacin in adult patients with
      community-acquired pneumonia.

      Besides, the populationpharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after
      continuous IV Infusion and the pharmacokinetic (PK)/pharmacodynamic (PD)are to be determined.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Per subject clinical cure rate
time frame: end of treatment and 7 to 14 days after the end of treatment
description: The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray
measure: Per subject microbiological cure rate
time frame: end of treatment and 7 to 14 days after the end of treatment
description: The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory
measure: Per subject overall cure rate
time frame: end of treatment and 7 to 14 days after the end of treatment
description: Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.
measure: Safety evaluation
time frame: duration of trial
description: Incidence and severity of AE and changes in safety parameters from baseline
arm group label: Nemonoxacin 500 mg
arm group type: Experimental
description: Nemonoxacin 500mg/250mL, intravenous administration, once daily for 7~14 days
arm group label: Levofloxacin 500mg
arm group type: Active Comparator
description: Levofloxacin: 500mg/100mL, intravenous administration, once daily for 7~14 days
intervention type: Drug
intervention name: Nemonoxacin
arm group label: Nemonoxacin 500 mg
intervention type: Drug
intervention name: Levofloxacin
arm group label: Levofloxacin 500mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
country: Taiwan
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Levofloxacin
mesh term: Nemonoxacin