A randomized, open, multicenter clinical study on the short course of intravenous infusion of 750 mg of levofloxacin and the sequential standard course of intravenous infusion/oral administration of 500 mg of levofloxacin for treatment of community-acquired pneumonia.
机构：[1]Respiratory Department of Chinese PLA General Hospital, Beijing 100853, China.[2]Respiratory Department of the 306th Hospital of Chinese PLA, Beijing 100101, China.[3]Respiratory Department of the 263th Hospital of Chinese PLA, Beijing 101149, China.[4]Respiratory Department of the First Affiliated Hospital of Guangzhou Medical College, Guangzhou 510120, China.[5]Respiratory Department of Huadong Hospital Affiliated to Fudan University, Shanghai 200040, China.[6]Respiratory Department of Peking University Third Hospital, Beijing 100191, China.[7]Respiratory Department of Luwan Branch of Ruijin Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200020, China.[8]Respiratory Department of Zhongshan Hospital, Fudan University, Shanghai 200032, China.[9]Respiratory Department of Shanghai Fifth People's Hospital, Fudan University, Shanghai 200240, China.[10]Respiratory Department of the Central Hospital of Minhang District, Shanghai Ruijin Hospital Group, Shanghai 201100, China.[11]Respiratory Department of the PLA Second Artillery General Hospital, Beijing 100088, China.[12]Respiratory Department of Peking University Shenzhen Hospital, Shenzhen 518036, China.[13]Respiratory Department of the First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China.内科系统呼吸内科浙江大学医学院附属第一医院[14]Respiratory Department of Fuxing Hospital Affiliated to Capital Medical University, Beijing 100038, China.[15]Respiratory Department of the First Affiliated Hospital of Shanghai Jiaotong University, Shanghai 200080, China.[16]Respiratory Department of Peking University People's Hospital, Beijing 100044, China.[17]Respiratory Department of Second Xiangya Hospital of Central South University, Changsha 410011, China.
To compare 5-day regimen of levofloxacin 750 mg IV daily with 7-14-day conventional regimen of levofloxacin 500 mg intravenous to oral (IV/PO) daily for treatment of community-acquired pneumonia (CAP) in Chinese population.
This was a non-inferiority study to assess the difference of clinical efficacy at the end of treatment (EOT) between two regimens. Adult CAP patients with CURB-65 score 0-2 were enrolled from 17 hospitals in China from November 2012 to July 2014. The subjects were randomized into levofloxacin 750 or 500 mg group and the clinical data were collected. Sputum and blood specimens were sent for bacterial culture. The urinary antigen of Streptococcus pneumoniae (S. pneumoniae) was detected as well. At EOT, the clinical efficacy (primary endpoint), microbiological efficacy and safety were evaluated.
A total of 457 patients were enrolled. Intent-to-treat (ITT) for primary endpoint analysis and per-protocol set (PPS) populations were 448 and 427 patients respectively. The therapeutic durations were 4.86 and 10.35 days and the mean drug exposure was 3,641.4 and 5,169.6 mg in 750 and 500 mg groups respectively. The clinical efficacy rate was 91.40% (202/221) in 750 mg group and 94.27% (214/227) in 500 mg group (ITT, P=0.2449). The difference in clinical efficacy rate was -2.87 (95% CI: -7.64, 1.90) between the two groups. The non-inferiority hypothesis of two groups was tenable (Δ=10%). The bacterial eradication rate was 100.00% in both groups. The most common drug-related clinical adverse events were injection site and gastrointestinal reactions. The most common drug-related laboratory abnormalities were WBC decrease and ALT/AST elevation. No statistical difference was found between two groups (P>0.05).
The 5-day regimen of levofloxacin 750 mg daily is non-inferior to 7-14-day conventional regimen of 500 mg daily in clinical efficacy for treatment of mild to moderate Chinese CAP population. The short course regimen allows the reduction of antimicrobial drug exposure and is well tolerated.
基金：
Daiichi Sankyo Co., Ltd.Daiichi Sankyo Company Limited
第一作者机构：[1]Respiratory Department of Chinese PLA General Hospital, Beijing 100853, China.
推荐引用方式(GB/T 7714)：
Zhao Tiemei,Chen Liang-An,Wang Ping,et al.A randomized, open, multicenter clinical study on the short course of intravenous infusion of 750 mg of levofloxacin and the sequential standard course of intravenous infusion/oral administration of 500 mg of levofloxacin for treatment of community-acquired pneumonia.[J].Journal of thoracic disease.2016,8(9):2473-2484.doi:10.21037/jtd.2016.08.30.
APA：
Zhao Tiemei,Chen Liang-An,Wang Ping,Tian Guizhen,Ye Feng...&Liu Youning.(2016).A randomized, open, multicenter clinical study on the short course of intravenous infusion of 750 mg of levofloxacin and the sequential standard course of intravenous infusion/oral administration of 500 mg of levofloxacin for treatment of community-acquired pneumonia..Journal of thoracic disease,8,(9)
MLA：
Zhao Tiemei,et al."A randomized, open, multicenter clinical study on the short course of intravenous infusion of 750 mg of levofloxacin and the sequential standard course of intravenous infusion/oral administration of 500 mg of levofloxacin for treatment of community-acquired pneumonia.".Journal of thoracic disease 8..9(2016):2473-2484
