Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP
NCT ID: NCT01529476
Last Updated: 2013-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
540 participants
INTERVENTIONAL
2011-04-30
2012-12-31
Brief Summary
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2. To investigate 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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Detailed Description
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Besides,the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Nemonoxacin 500 mg
Nemonoxacin
Nemonoxacin 500mg,QD,7\~10 days
Levofloxacin 500 mg
Levofloxacin
levofloxacin 500 mg,QD,7\~10 days
Interventions
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Levofloxacin
levofloxacin 500 mg,QD,7\~10 days
Nemonoxacin
Nemonoxacin 500mg,QD,7\~10 days
Eligibility Criteria
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Inclusion Criteria
2. Weighs between 40 \~ 100 kg, and BMI ≥ 18 kg/m2;
3. Must have a clinical diagnosis of CAP
4. Chest X-ray shows new or persist/progressive infiltrates
5. If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
6. The patient is able to take the drug orally.
Exclusion Criteria
2. Known or suspected severe bronchiectasis, cystic fibrosis, active pulmonary tuberculosis or infection with other mycobacteria or fungi, known bronchial obstruction, a history of post-obstructive pneumonia, other confounding respiratory diseases, such as lung cancer, malignancy metastatic to the lungs, lung abscess, empyema, suspected aspiration pneumonia due to vomiting, or non-bacterial respiratory infection (chronic obstructive pulmonary disease \[COPD\] is not exclusionary)
3. Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval
4. Potassium is \< 3.5 mmol/L
5. Any known disease that seriously affect the immune system
6. Active hepatitis or decompensated cirrhosis;
7. Have used quinolones or fluoroquinolones within 14 days before enrollment
8. Patients who are being or will be on a long-term medication of steroids
18 Years
70 Years
ALL
No
Sponsors
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Qualitix Clinical Research Co., Ltd.
INDUSTRY
Parexel
INDUSTRY
PPD Development, LP
INDUSTRY
TaiGen Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Anzhen Hospital,Beijing Capital Medical University
Anzhen, , China
Beijing Union Medical College Hospital
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
Countries
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References
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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.
Other Identifiers
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TG-873870-C-4
Identifier Type: -
Identifier Source: org_study_id
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