NCT01529476

Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: TaiGen Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pneumonia

Interventions

Type	Name	Description
DRUG	Levofloxacin	levofloxacin 500 mg,QD,7\~10 days
DRUG	Nemonoxacin	Nemonoxacin 500mg,QD,7\~10 days

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-08-01
• Completion: 2012-12-01
• First posted: 2012-02-08
• Last updated: 2013-06-18

Locations

57 sites across 2 countries: China, Taiwan