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The purpose of this study is to evaluate the safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.
Evaluate clinical efficacy, microbiological efficacy and safety of Nemonoxacin adult patients with community-acquired pneumonia (CAP); and
A study on the population pharmacokinetics (PPK) of continuous oral administration of Nemonoxacin in adult patients with CAP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nemonoxacin 750 mg | Active Comparator | Nemonoxacin 750 mg 2 tablets. |
|
| Nemonoxacin 500 mg | Active Comparator | Nemonoxacin 500 mg 3 tablets |
|
| Levofloxacin 500 mg | Active Comparator | Levofloxacin 500 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levofloxacin 500 mg placebol | Drug | oral form,,once adily,7~10 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Per subject clinical cure rate | Clinical cure rate equals to number of clinical evaluable divided by number of clinical cured. If subject's clnical outcome is evaluable by principal invastigator, he/she is defined as clinical evaluable. | 16days |
| Per subject microbiological cure rate | Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated. | 16days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of nemonoxacin in CAP subjects | 3days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yingyuan Zhang, PhD | Huashan Hospital, Fundan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital, Capital Medical University | Beijing | China | ||||
| Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26748734 | Derived | Liu Y, Zhang Y, Wu J, Zhu D, Sun S, Zhao L, Wang X, Liu H, Ren Z, Wang C, Xiu Q, Xiao Z, Cao Z, Cui S, Yang H, Liang Y, Chen P, Lv Y, Hu C, Lv X, Liu S, Kuang J, Li J, Wang D, Chang L. A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia. J Microbiol Immunol Infect. 2017 Dec;50(6):811-820. doi: 10.1016/j.jmii.2015.09.005. Epub 2015 Dec 1. |
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| Levofloxacin 500 mg placebol |
| Drug |
oral form,,once adily,7~10 days |
|
| Nemonoxacin 3 tablets | Drug | oral form,once daily,7~10 days |
|
| Beijing |
| China |
| Peking University First Hospital | Beijing | China |
| Peking University People's Hospital | Beijing | China |
| PLA Second Artillery General Hospital | Beijing | China |
| Zhen Hospital, Capital Medical University Beijing | Beijing | China |
| Daping Hospital, Third Military Medical University | Chongqing | China |
| First Affiliated Hospital of Fujian Medical University | Fujian | China |
| Gansu Provincial People's Hospital | Gansu | China |
| Guangzhou Red Cross Hospital | Guangzhou | China |
| Second Affiliated Hospital of Sun Yat-sen | Guangzhou | China |
| Affiliated Hospital of Guilin Medical College | Guilin | China |
| Taihe Hospital in Shiyan City, Hubei Province | Hubei | China |
| Third Xiangya Hospital, Central South University | Hunan | China |
| Jiangxi Provincial People's Hospital | Jiangxi | China |
| Second Affiliated Hospital of Nanchang University | Jiangxi | China |
| Jinan Central Hospital | Jinan | China |
| Shengjing Hospital of China Medical University | Liaoning | China |
| Nanjing General Hospital of Nanjing Military Region | Nanjing | China |
| Huashan Hospital ,Fudan University | Shanghai | China |
| Institute of Antibiotics, Huashan Hospital, Fundan University | Shanghai | China |
| Institute of Antibiotics,Huashan Hospital ,Fudan University | Shanghai | China |
| Shanghai Pudong New Area, Oriental Hospital | Shanghai | China |
| Shanghai Putuo District Central Hospital | Shanghai | China |
| First Hospital of Shanxi Medical University | Shanxi | China |
| People's Liberation Army General Hospital of Shenyang Military Region | Shenyang | China |
| Shenzhen People's Hospital | Shenzhen | China |
| West China Hospital of Sichuan University (Respiratory) | Sichuan | China |
| Second Affiliated Hospital of Wenzhou Medical College | Wenzhou | China |
| People's Hospital of Wuhan University | Wuhan | China |
| Wuhan General Hospital of PLA Guangzhou Military Region | Wuhan | China |
| First Affiliated Hospital, Zhejiang University School of Medicine | Zhejiang | China |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| 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 |
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