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

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).

Timeline

Start

2011-04

Primary completion

2012-08

Completion

2012-12

Publications

• Yuan J, Mo B, Ma Z, Lv Y, Cheng SL, Yang Y, Tong Z, Wu R, Sun S, Cao Z, Wu J, Zhu D, Chang L, Zhang Y; Investigator Group of the Phase 3 Study on Oral Nemonoxacin. Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial. J Microbiol Immunol Infect. 2019 Feb;52(1):35-44. doi: 10.1016/j.jmii.2017.07.011. Epub 2017 Aug 2.

Drugs

Indications