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| Name | Class |
|---|---|
| Qualitix Clinical Research Co., Ltd. | INDUSTRY |
| Parexel | INDUSTRY |
| PPD Development, LP | INDUSTRY |
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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 test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP).
Besides,the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nemonoxacin 500 mg | Experimental |
| |
| Levofloxacin 500 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levofloxacin | Drug | levofloxacin 500 mg,QD,7~10 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Per subject clinical cure rate | The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray. | 21days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation | Clinical adverse events and abnormal laboratory or other special test findings during this study should be observed and recorded carefully. | 24days |
| Per subject microbiological cure rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anzhen Hospital,Beijing Capital Medical University | Anzhen | China | ||||
| Beijing Union Medical College Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30181096 | Derived | Yuan J, Mo B, Ma Z, Lv Y, Cheng SL, Yang Y, Tong Z, Wu R, Sun S, Cao Z, Wu J, Zhu D, Chang L, Zhang Y; Investigator Group of the Phase 3 Study on Oral Nemonoxacin. Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial. J Microbiol Immunol Infect. 2019 Feb;52(1):35-44. doi: 10.1016/j.jmii.2017.07.011. Epub 2017 Aug 2. |
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| Nemonoxacin |
| Drug |
Nemonoxacin 500mg,QD,7~10 days |
|
The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory
| 14 days |
| Per subject overall cure rate | Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results. | 14 days |
| Beijing |
| China |
| General Hospital of PLA Second Artillery | Beijing | China |
| Peking University First Hospital | Beijing | China |
| Peking University People's Hospital | Beijing | China |
| Beijing Chaoyang Hospital | Chaoyang | China |
| West China Hospital of Sichuan University,Center for Infection Disease | Chengdu | China |
| PLA Third Militrary Medical University,Second Affiliated Hospital | Chongqing | China |
| PLA Third Militrary Medical University,Third Affiliated Hospital | Chongqing | China |
| The First Affiliated Hospital,Chongqing Medical University | Chongqing | China |
| The First Hospital of Fujian Medical University | Fuzhou | China |
| People's Hospital of Gansu Province | Gansu | China |
| GuangZhou Red Cross Hospital | Guangzhou | China |
| Sun Yet-sen Memorial Hospital | Guangzhou | China |
| Affilated Hospital of Guilin Medical college | Guilin | China |
| Hainan Provincial People's Hospital | Hainan | China |
| Hospital Affiliated to Hainan Medical College | Hainan | China |
| Hubei General Hospital | Hubei | China |
| Taihe Hospital | Hubei | China |
| Hunan Provincial People's Hospital | Hunan | China |
| Third Xiangya Hospital,Central South University | Hunan | China |
| People's Hospital of Jiangxi Province | Jiangxi | China |
| Jinan Central Hospital | Jinan | China |
| Lanzhou university second hospital | Lanzhou | China |
| Shengjing Hospital of China Medical University | Liaoning | China |
| Second Affiliated Hospital of Nanchang University | Nanchang | China |
| Nanjing Genrak Hospital of Nanjing Millitary Command | Nanjing | China |
| Huadong Hospital of Fudan University | Shanghai | China |
| Putuo Central Hospital | Shanghai | China |
| Shanghai Changzheng Hospital | Shanghai | China |
| Shanghai East Hospital in Pudong New Area | Shanghai | China |
| Shanghai Sixth People's Hospital | Shanghai | China |
| The First Hospital of Shanxi Medical College | Shanxi | China |
| PLA General Hospital of Shenyang Military Region | Shenyang | China |
| ShenZhen People's Hospital | Shenzhen | China |
| Institute of Antibiotics,Huashan Hospital ,Fudan University | Shianghai | China |
| Department of Resoiratory Medicine,West China Hospital of Sichuan University | Sichuan | China |
| Shuang Ho Hospital | Taipei | China |
| The Second Hospital of Wenzhou Medical College | Wenzhou | China |
| Wuhan General Hospital of Guangzhou Millitary Command | Wuhan | China |
| The First Affiliated Hospital,Xinjiang Medical University | Xinjiang | China |
| First Affiliated Hospital,Zhejiang University School of Medicine | Zhejiang | China |
| Chia-Yi Christian Hospital | Chiayi City | Taiwan |
| E-Da Hospital | Kaohsiung City | Taiwan |
| Kaohsiung hang Gung Memorial Hospital | Kaohsiung City | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan |
| Yuan's General Hospital | Kaohsiung City | Taiwan |
| ChiMei Medical Hospital-Liuying branch | Liuying | Taiwan |
| Cheng Ching General Hospital | Taichung | Taiwan |
| China Medical University Hospital | Taichung | Taiwan |
| Chung Shan Medical University Hospital | Taichung | Taiwan |
| Veterans General Hospital-TaiChung | Taichung | Taiwan |
| Cheng Hsin General Hospital | Taipei | Taiwan |
| Far-East Memorial Hospital | Taipei | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Tri-Service General Hospital | Taipei | Taiwan |
| Veterans General Hospital-Taipei | Taipei | Taiwan |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| C543520 | nemonoxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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