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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
540
levofloxacin 500 mg,QD,7\~10 days
Nemonoxacin 500mg,QD,7\~10 days
Per subject clinical cure rate
The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray.
Time frame: 21days
Safety Evaluation
Clinical adverse events and abnormal laboratory or other special test findings during this study should be observed and recorded carefully.
Time frame: 24days
Per subject microbiological cure rate
The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory
Time frame: 14 days
Per subject overall cure rate
Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.
Time frame: 14 days
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