Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01529476|
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : June 18, 2013
- 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).
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia||Drug: Levofloxacin Drug: Nemonoxacin||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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)|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||December 2012|
|Experimental: Nemonoxacin 500 mg||
Nemonoxacin 500mg,QD,7~10 days
|Active Comparator: Levofloxacin 500 mg||
levofloxacin 500 mg,QD,7~10 days
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529476