Vol.59 No.S-1 May 2011
Clinical phase III comparative study of intravenous levofloxacin and ceftriaxone in community-acquired pneumonia treatment
1)Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki, Japan
2)Research Division for Development of Anti-Infective Agents, Institute of Development, Aging and Cancer, Tohoku University
3)Department of Internal Medicine, Shinrakuen Hospital
4)Department of Clinical Infectious Diseases, School of Medicine, Showa University
5)Department of Internal Medicine 2, Oita University Faculty of Medicine
6)Department of Medicine and Therapeutics Control and Prevention of Infectious Diseases, Faculty of Medicine, University of the Ryukyus
7)Department of Laboratory Medicine, Nagasaki University Hospital
8)Department of Infection Control and Laboratory Diagnostics, Internal Medicine, Tohoku University Graduate School of Medicine
9)Department of Pharmacology, Jikei University School of Medicine
(Present: Department of Infectious Diseases and Infection Control, Jikei University School of Medicine)
Abstract
To evaluate the efficacy and safety of intravenous levofloxacin(LVFX) in adults with community-acquired bacterial but not atypical organismic pneumonia, we conducted a multicenter randomized open-label non-inferiority study using ceftriaxone(CTRX) as a comparator. Subjects were randomized through central registration to be administered LVFX 500 mg once daily or CTRX 1 g twice daily as an intravenous infusion for 7 to 14 days.
Clinical efficacy: At the end of treatment, clinical response was 88.5% (92/104) in LVFX-treated and 88.8% (79/89) in CTRX-treated. The intergroup difference was -0.3% (95% confidence interval, -9.3 to 8.7) and non-inferiority of LVFX versus CTRX was established.
Microbiologic efficacy: Eradication at the end of treatment was achieved in 96.7% (59/61) treated with LVFX and 97.8% (44/45) treated with CTRX. The intergroup difference was -1.1% (95% confidence interval, -7.3 to 5.1).
Safety: Adverse drug reactions were reported in 53.7% (73/136) treated with LVFX and 56.9% (70/123) treated with CTRX. The intergroup difference was -3.2% (95% confidence interval, -15.4 to 8.9).
Our results showed that intravenous LVFX 500 mg once daily is as effective and safe as CTRX 1 g twice daily in treating community-acquired bacterial pneumonia.
Key word
levofloxacin injection, community-acquired pneumonia, randomized-controlled trial
Received
November 10, 2010
Accepted
March 8, 2011
Jpn. J. Chemother. 59 (S-1): 32-45, 2011
