NCT01944774

Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride

A Multi-Center, Randomized, Double-Blind, Parallel Comparative, Phase II Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Versus Moxifloxacin in Treating Adult Patients With Community-Acquired Pneumonia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: TaiGen Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to Evaluate the Efficacy, safety and pharmacokinetics of Intravenous Nemonoxacin Compared with Intravenous Moxifloxacin in Adult Patients with community-acquired pneumonia (CAP).

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 Evaluate the clinical efficacy, microbiological efficacy and safety of Intravenous Nemonoxacin compared with Intravenous Moxifloxacin in adult patients with community-acquired pneumonia. Besides, the pharmacokinetics (PK) of Nemonoxacin in adult patients with CAP after continuous IV Infusion and the pharmacokinetic (PK)/pharmacodynamic (PD)are to be determined.

Conditions

• Pneumonia

Interventions

Type	Name	Description
DRUG	Nemonoxacin 500 mg	IV Infusion, once daily for 7\~14 days
DRUG	Nemonoxacin 650 mg	IV Infusion, once daily for 7\~14 days
DRUG	Moxifloxacin 400 mg	IV Infusion, once daily for 7\~14 days

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-09-18
• Last updated: 2025-07-01
• Results posted: 2015-02-18

Locations

2 sites across 2 countries: China, Taiwan