Tiemei Zhao1, Liang-An Chen1, Ping Wang2, Guizhen Tian3, Feng Ye4, Huili Zhu5, Bei He6, Baiying Zhang7, Changzhou Shao8, Zhijun Jie9, Xiwen Gao10, Dongxia Wang11, Weidong Song12, Zhijie Pan13, Jin Chen14, Xingyi Zhang15, Zhancheng Gao16, Ping Chen17, Youning Liu1. 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. 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.
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 of Streptococcus 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.
RCT Entities:
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 of Streptococcus 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: Elliott Frank; Jing Liu; Gary Kinasewitz; Gregory J Moran; Margaret P Oross; William H Olson; Veronica Reichl; Susan Freitag; Neelam Bahal; Barbara A Wiesinger; Alan Tennenberg; James B Kahn Journal: Clin Ther Date: 2002-08 Impact factor: 3.393
Authors: Lala M Dunbar; Richard G Wunderink; Michael P Habib; Leon G Smith; Alan M Tennenberg; Mohammed M Khashab; Barbara A Wiesinger; Jim X Xiang; Neringa Zadeikis; James B Kahn Journal: Clin Infect Dis Date: 2003-08-28 Impact factor: 9.079
Authors: Jesús López-Alcalde; Ricardo Rodriguez-Barrientos; Jesús Redondo-Sánchez; Javier Muñoz-Gutiérrez; José María Molero García; Carmen Rodríguez-Fernández; Julio Heras-Mosteiro; Jaime Marin-Cañada; Jose Casanova-Colominas; Amaya Azcoaga-Lorenzo; Virginia Hernandez Santiago; Manuel Gómez-García Journal: Cochrane Database Syst Rev Date: 2018-09-06