Vol.57 No.S-2 July 2009
Clinical response of levofloxacin 500 mg qd to complicated urinary tract infection -efficacy of 7- and 14-day administration-
1)Department of Urology, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan
2)Department of Urology, Gifu University Graduate School of Medicine
3)Surgical Division/Department of Infection Control and Prevention, Kobe University Hospital
4)Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
5)Department of Pharmacology, Jikei University School of Medicine
Abstract
Japanese patients with complicated urinary tract infection(UTI)(N=185) were treated with 500 mg of levofloxacin(LVFX) once daily (qd) for 7 or 14 days based on the open label method to assess LVFX dose regimen efficacy and safety.
Clinical efficacy was evaluated based on Criteria for Evaluation of Clinical Efficacy of Antimicrobial Agents on Urinary Tract Infection (draft fourth edition). Assessment at study completion (early evaluation) showed overall clinical efficacy of 83.4% (131/157). The microbiological response (i.e., eradication) of all causative organisms was 88.8% (215/242).
Assessment at 5-9 days after study completion (late evaluation) showed eradication (microbiological outcome) of 60.9% (95/156) and cure (clinical outcome) of 59.6% (81/136).
At 4-6 weeks after study completion (follow-up evaluation), eradication (microbiological outcome) was 76.9% (70/91) and cure (clinical outcome) was 73.2% (60/82).
The incidence of adverse events was 33.0% (61/185) and that of adverse drug reactions 17.8% (33/185). All adverse drug reactions reported were mild or moderate in severity and represented known adverse LVFX reactions.
These results suggest that 500 mg qd of LVFX shows an adequate therapeutic effect and present no significant safety concerns in patients with complicated UTI.
Key word
levofloxacin, complicated urinary tract infection, clinical study, once-a-day
Received
December 17, 2008
Accepted
January 23, 2009
Jpn. J. Chemother. 57 (S-2): 34-46, 2009
