Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP
- Registration Number
- NCT01529476
- Lead Sponsor
- TaiGen Biotechnology Co., Ltd.
- Brief Summary
1. This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP)
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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 540
- Ages between 18 and 70;
- Weighs between 40 ~ 100 kg, and BMI ≥ 18 kg/m2;
- Must have a clinical diagnosis of CAP
- Chest X-ray shows new or persist/progressive infiltrates
- If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
- The patient is able to take the drug orally.
- Patients with CAP that, in the investigator's judgment, is severe enough to require hospitalization for intravenous antibiotic therapy and/or supplemental oxygen therapy with ICU support
- 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)
- Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval
- Potassium is < 3.5 mmol/L
- Any known disease that seriously affect the immune system
- Active hepatitis or decompensated cirrhosis;
- Have used quinolones or fluoroquinolones within 14 days before enrollment
- Patients who are being or will be on a long-term medication of steroids
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nemonoxacin 500 mg Nemonoxacin - Levofloxacin 500 mg Levofloxacin -
- Primary Outcome Measures
Name Time Method Per subject clinical cure rate 21days The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray.
- Secondary Outcome Measures
Name Time Method Safety Evaluation 24days Clinical adverse events and abnormal laboratory or other special test findings during this study should be observed and recorded carefully.
Per subject microbiological cure rate 14 days The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory
Per subject overall cure rate 14 days Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.
Trial Locations
- Locations (57)
Beijing Union Medical College Hospital
🇨🇳Beijing, China
China Medical University Hospital
🇨🇳Taichung, Taiwan
Anzhen Hospital,Beijing Capital Medical University
🇨🇳Anzhen, China
Sun Yet-sen Memorial Hospital
🇨🇳Guangzhou, China
Huadong Hospital of Fudan University
🇨🇳Shanghai, China
Wuhan General Hospital of Guangzhou Millitary Command
🇨🇳Wuhan, China
People's Hospital of Gansu Province
🇨🇳Gansu, China
GuangZhou Red Cross 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
Peking University People's Hospital
🇨🇳Peking, China
Putuo Central Hospital
🇨🇳Shanghai, China
Shanghai Changzheng Hospital
🇨🇳Shanghai, China
Shanghai East Hospital in Pudong New Area
🇨🇳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
Shanghai Sixth People's Hospital
🇨🇳Shanghai, China
Shuang Ho Hospital
🇨🇳Taipei, China
The Second Hospital of Wenzhou Medical College
🇨🇳Wenzhou, China
First Affiliated Hospital,Zhejiang University School of Medicine
🇨🇳Zhejiang, China
Chia-Yi Christian Hospital
🇨🇳Chia-Yi, Taiwan
Yuan's General Hospital
🇨🇳Kaohsiung, Taiwan
Veterans General Hospital-Taipei
🇨🇳Taipei, Taiwan
ChiMei Medical Hospital-Liuying branch
🇨🇳Liuying, Taiwan
Cheng Ching General Hospital
🇨🇳Taichung, Taiwan
Veterans General Hospital-TaiChung
🇨🇳TaiChung, Taiwan
General Hospital of PLA Second Artillery
🇨🇳Beijing, China
West China Hospital of Sichuan University,Center for Infection Disease
🇨🇳Chengdu, China
PLA Third Militrary Medical University,Second Affiliated Hospital
🇨🇳Chongqing, China
Beijing Chaoyang Hospital
🇨🇳Chaoyang, 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
The First Affiliated Hospital,Xinjiang Medical University
🇨🇳Xinjiang, China
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
Kaohsiung hang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Cheng Hsin General Hospital
🇨🇳Taipei, Taiwan
E-Da Hospital
🇨🇳Kaohsiung, Taiwan
Far-East Memorial Hospital
🇨🇳Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Nanjing Genrak Hospital of Nanjing Millitary Command
🇨🇳Nanjing, China
Peking University First Hospital
🇨🇳Peking, China