Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nemonoxacin 500 mg | Experimental | Nemonoxacin 500mg/250mL, intravenous administration, once daily for 7~14 days |
|
| Levofloxacin 500mg | Active Comparator | Levofloxacin: 500mg/100mL, intravenous administration, once daily for 7~14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemonoxacin | Drug |
| ||
| Levofloxacin |
| 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 | end of treatment and 7 to 14 days after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Per subject microbiological cure rate | The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory | end of treatment and 7 to 14 days after the end of treatment |
| Per subject overall cure rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baotou Central Hospital | Baotou | China | ||||
| Aerospace Center Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
|
Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results. |
| end of treatment and 7 to 14 days after the end of treatment |
| Safety evaluation | Incidence and severity of AE and changes in safety parameters from baseline | duration of trial |
| Beijing |
| China |
| Affiliated Beijing Anzhen Hospital of Capital Medical University | Beijing | China |
| Affiliated Beijing Chaoyang Hospital of Capital Medical University | Beijing | China |
| Chinese People's Liberation Army General Hospital | Beijing | China |
| Institute of Clinical Pharmacology, Peking University | Beijing | China |
| Peking University People's Hospital | Beijing | China |
| Changsha Central Hospital | Changsha | China |
| The Third Changsha Hotpital | Changsha | China |
| The Third Xiangya Hospital of Central South University | Changsha | China |
| Daping Hospital | Chongqing | China |
| Guangxi Zhuang Autonomous Region People's Hospital | Guangxi | China |
| First Affiliated Hospital of Guangzhou Medical University | Guangzhou | China |
| Guilin Medical School Affiliated Hospital | Guilin | China |
| Hainan General Hospital | Haikou | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | China |
| The Second Affiliated Hospital of Zhejiang University | Hangzhou | China |
| The First Hospital of Anhui Medical University | Hefei | China |
| The Affilated Hospital of Inner Mongolia Medical University | Hohhot | China |
| The First Hospital of Jilin University | Jilin City | China |
| The Fourth Hospital of Jilin University | Jilin City | China |
| Jinan Central Hospital | Jinan | China |
| The Second Hospital of Shandong University | Jinan | China |
| Gansu Provincial People's Hospital | Lanzhou | China |
| Jiangxi Provincial People's Hospital | Nanchang | China |
| Second Subsidiary Hospital of Nanchang Medical College | Nanchang | China |
| General Hospital of Nanjing Military Command | Nanjing | China |
| Institute of Antibiotics, Huashan Hospital, Fundan University | Shanghai | 200040 | China |
| Huadong Hospital Affiliated to Fudan University | Shanghai | China |
| Shanghai East Hospital of Tongji University | Shanghai | China |
| Shanghai Pulmonary Hospital | Shanghai | China |
| General Hospital of Shenyang Military | Shenyang | China |
| Shengjing Hospital | Shenyang | China |
| Shenzhen People's Hospital | Shenzhen | China |
| The Second People's Hospital of Shenzhen | Shenzhen | China |
| General Hospital of Chengdu Military Region | Sichuan | China |
| West China Center of Medical Sciences of Sichuan University | Sichuan | China |
| First Hospital of Shanxi Medical University | Taiyuan | China |
| Wuxi People's Hospital | Wuxi | China |
| Tangdu Hospital | Xi'an | China |
| The First Affilated Hospital of Xiamen University | Xiamen | China |
| Northern Jiangsu People's Hospital | Yangzhou | China |
| The First Affiliated Hospital,College of Medicine,Zhejiang University | Zhejiang | China |
| Changhua Christian Hospital | Chang-hua | Taiwan |
| Chiayi Chang Gung Memorial Hospital | Chiayi City | Taiwan |
| NTUH Hsin-Chu Branch | Hsinchu | Taiwan |
| Hualien Tzu Chi Hospital | Hualien City | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | Taiwan |
| Keelung Chang Gung Memorial Hospital | Keelung | Taiwan |
| Far Eastern Memorial Hospital | New Taipei City | Taiwan |
| MacKay Memorial Hospital | New Taipei City | Taiwan |
| China Medical University Hospital | Taichung | Taiwan |
| Chung Shan Medical University Hospital | Taichung | Taiwan |
| Taichung Veterans General Hospital | Taichung | Taiwan |
| Chi Mei Hospital, Liouying | Tainan | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Medical University - Shuang Ho Hospital | Taipei | Taiwan |
| Taipei Medical University Hospital | Taipei | Taiwan |
| Taipei Municipal Wanfang Hospital | Taipei | Taiwan |
| Tri-Service General Hospital | Taipei | Taiwan |
| NTUH Yun-Lin Branch | Yuli | Taiwan |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C543520 | nemonoxacin |
| D064704 | Levofloxacin |
| 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 |
Not provided
Not provided