title: 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.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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 ofStreptococcus pneumoniae(S. pneumoniae) was detected as well. At EOT, the clinical efficacy (primary endpoint), microbiological efficacy and safety were evaluated.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Respiratory Department of Chinese PLA General Hospital, Beijing 100853, China.
authors.forename: Tiemei
authors.initials: T
authors.lastname: Zhao
authors.affiliation: Respiratory Department of Chinese PLA General Hospital, Beijing 100853, China.
authors.forename: Liang-An
authors.initials: LA
authors.lastname: Chen
authors.affiliation: Respiratory Department of the 306th Hospital of Chinese PLA, Beijing 100101, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Wang
authors.affiliation: Respiratory Department of the 263th Hospital of Chinese PLA, Beijing 101149, China.
authors.forename: Guizhen
authors.initials: G
authors.lastname: Tian
authors.affiliation: Respiratory Department of the First Affiliated Hospital of Guangzhou Medical College, Guangzhou 510120, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Ye
authors.affiliation: Respiratory Department of Huadong Hospital Affiliated to Fudan University, Shanghai 200040, China.
authors.forename: Huili
authors.initials: H
authors.lastname: Zhu
authors.affiliation: Respiratory Department of Peking University Third Hospital, Beijing 100191, China.
authors.forename: Bei
authors.initials: B
authors.lastname: He
authors.affiliation: Respiratory Department of Luwan Branch of Ruijin Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200020, China.
authors.forename: Baiying
authors.initials: B
authors.lastname: Zhang
authors.affiliation: Respiratory Department of Zhongshan Hospital, Fudan University, Shanghai 200032, China.
authors.forename: Changzhou
authors.initials: C
authors.lastname: Shao
authors.affiliation: Respiratory Department of Shanghai Fifth People's Hospital, Fudan University, Shanghai 200240, China.
authors.forename: Zhijun
authors.initials: Z
authors.lastname: Jie
authors.affiliation: Respiratory Department of the Central Hospital of Minhang District, Shanghai Ruijin Hospital Group, Shanghai 201100, China.
authors.forename: Xiwen
authors.initials: X
authors.lastname: Gao
authors.affiliation: Respiratory Department of the PLA Second Artillery General Hospital, Beijing 100088, China.
authors.forename: Dongxia
authors.initials: D
authors.lastname: Wang
authors.affiliation: Respiratory Department of Peking University Shenzhen Hospital, Shenzhen 518036, China.
authors.forename: Weidong
authors.initials: W
authors.lastname: Song
authors.affiliation: Respiratory Department of the First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China.
authors.forename: Zhijie
authors.initials: Z
authors.lastname: Pan
authors.affiliation: Respiratory Department of Fuxing Hospital Affiliated to Capital Medical University, Beijing 100038, China.
authors.forename: Jin
authors.initials: J
authors.lastname: Chen
authors.affiliation: Respiratory Department of the First Affiliated Hospital of Shanghai Jiaotong University, Shanghai 200080, China.
authors.forename: Xingyi
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Respiratory Department of Peking University People's Hospital, Beijing 100044, China.
authors.forename: Zhancheng
authors.initials: Z
authors.lastname: Gao
authors.affiliation: Respiratory Department of Second Xiangya Hospital of Central South University, Changsha 410011, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Chen
authors.affiliation: Respiratory Department of Chinese PLA General Hospital, Beijing 100853, China.
authors.forename: Youning
authors.initials: Y
authors.lastname: Liu
keywords: Community-acquired pneumonia (CAP); effectiveness; levofloxacin; safety