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).
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 levofloxacin in adult patients with community-acquired pneumonia. Besides, the populationpharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous IV Infusion and the pharmacokinetic (PK)/pharmacodynamic (PD)are to be determined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
598
Per subject clinical cure rate
The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray
Time frame: end of treatment and 7 to 14 days after the end of treatment
Per subject microbiological cure rate
The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory
Time frame: end of treatment and 7 to 14 days after the end of treatment
Per subject overall cure rate
Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.
Time frame: end of treatment and 7 to 14 days after the end of treatment
Safety evaluation
Incidence and severity of AE and changes in safety parameters from baseline
Time frame: duration of trial
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Baotou Central Hospital
Baotou, China
Aerospace Center Hospital
Beijing, China
Affiliated Beijing Anzhen Hospital of Capital Medical University
Beijing, China
Affiliated Beijing Chaoyang Hospital of Capital Medical University
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Chinese People's Liberation Army General Hospital
Beijing, China
Institute of Clinical Pharmacology, Peking University
Beijing, China
Peking University People's Hospital
Beijing, China
Changsha Central Hospital
Changsha, China
The Third Changsha Hotpital
Changsha, China
The Third Xiangya Hospital of Central South University
Changsha, China
...and 53 more locations