Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP
- This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP)
- To investigate the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Comparative, Multi-Center Study of the Safety and Efficacy of TG-873870(Nemonoxacin) Versus Levofloxacin in Adult Patients With Community-Acquired Pneumonia (CAP)|
- Per subject clinical cure rate [ Time Frame: 21days ]The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray.
- Safety Evaluation [ Time Frame: 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 [ Time Frame: 14 days ]The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory
- Per subject overall cure rate [ Time Frame: 14 days ]Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.
|Study Start Date:||April 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
|Experimental: Nemonoxacin 500 mg||
Nemonoxacin 500mg,QD,7~10 days
|Active Comparator: Levofloxacin 500 mg||
levofloxacin 500 mg,QD,7~10 days
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529476
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