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Diagn Microbiol Infect Dis. 2014 Oct;80(2):141-7. doi: 10.1016/j.diagmicrobio.2013.11.008. Epub 2013 Nov 15.

A randomized controlled clinical trial of levofloxacin 750 mg versus 500 mg intravenous infusion in the treatment of community-acquired pneumonia.

Author information

1
Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai 200040, China.
2
Department of Respiratory Medicine, Shanghai Changzheng Hospital, Shanghai 200003, China.
3
Department of Respiratory Medicine, Beijing Chao-yang Hospital, Capital Medical University, Beijing 100002, China.
4
Department of Respiratory Medicine, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing 210008, China.
5
Department of Respiratory Medicine, The First Affiliated Hospital of Soochow University, Suzhou 215006, China.
6
Department of Respiratory Medicine, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510080, China.
7
Department of Respiratory Medicine, The Third Xiangya Hospital of Central South University, Changsha 410003, China.
8
Department of Infectious Diseases, West China Hospital, Sichuan University, Chengdu 610041, China.
9
Department of Respiratory Medicine, The Wuhan General Hospital of Guangzhou Military, Wuhan 430070, China.
10
Department of Respiratory Medicine, The Jiangxi Provincial People's Hospital, Nanchang 330006, China.
11
Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai 200040, China. Electronic address: yyzhang39@hotmail.com.

Abstract

The objective of this study was to compare the efficacy and safety of levofloxacin 750 mg for 5 days versus 500 mg for 7-14 days intravenous (IV) in the treatment of community-acquired pneumonia (CAP). This clinical trial was the first of its kind conducted in Chinese people and also in Asian population. A total of 241 were enrolled and randomized to 750 mg group (n = 121) or 500 mg (n = 120) group from 10 study centers. The median treatment duration was 5.0 days in 750 mg and 9.0 days in 500 mg group. The median total dose was 3750 mg in 750 mg and 4500 mg in 500 mg group. The bacterial eradication rate was 100% in both groups. The overall efficacy rate in 750 mg group was 86.2% (94/109), and 84.7% (94/111), in 500 mg group of full analysis set visit 4, 95% confidence interval of 1.6% (-7.8-10.9%); the statistical results showed that 750 mg group was non-inferior to 500 mg group. The most common clinical adverse drug reactions were injection site adverse reactions in both 750 mg group and 500 mg group; the other common adverse drug reactions were insomnia, nausea, skin rash, etc. The most common drug-related laboratory abnormalities were neutrophil percentage decreased, decreased white blood cell count, alanine aminotransferase, and aspartate aminotransferase elevation in both 750 mg group and 500 mg group. Most of adverse drug reactions were mild in severity and well-tolerated. In summary, the regimen of levofloxacin 750 mg IV for 5 days was at least as effective and well tolerated as 500 mg IV for 7-14 days for the treatment of CAP.

KEYWORDS:

Clinical trial; Community-acquired pneumonia; Efficacy; Levofloxacin; Safety

[Indexed for MEDLINE]

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