Vol.64 No.6 November 2016
A phase III, randomized, open-label study of sequential intravenous/oral levofloxacin in comparison to sequential intravenous pazufloxacin/oral levofloxacin in adult patients with urinary tract infection
1)Department of Urology, Gifu University Hospital, 1-1, Yanagito, Gifu, Japan
2)Department of Urology, University of Occupational and Environmental Health, Japan
3)Department of Urology, Hyogo College of Medicine
4)R&D Division, Daiichi Sankyo Co., Ltd.
5)Professor emeritus, University of Occupational and Environmental Health, Japan
Abstract
We conducted a multicenter, randomized, open-label non-inferiority study to evaluate the efficacy and safety of intravenous (IV) levofloxacin (LVFX) 500 mg administered once daily in hospitalized adult patients with urinary tract infections as compared to intravenous pazufloxacin (PZFX) 500 mg twice daily. The target subjects of the study were patients with acute uncomplicated pyelonephritis, complicated pyelonephritis or complicated cystitis. The subjects were randomized through central registration to a group administered LVFX 500 mg IV once daily for 5 days followed by oral LVFX 500 mg once daily for 5 days (LVFX/LVFX group), or to a group administered PZFX 500 mg IV twice daily for 5 days followed by oral LVFX 500 mg once daily for 5 days (PZFX/LVFX group). The clinical efficacy was evaluated based on the Japanese Guideline for Clinical Research of Antimicrobial Agents on Urogenital Infections (the first edition).
The primary endpoint was the efficacy rate in terms of the microbial eradication rate at the end of the IV treatment period. The efficacy rate was 93.7% (119/127) after IV LVFX treatment in the LVFX/LVFX group and 89.5% (111/124) for IV PZFX treatment in the PZFX/LVFX group; the difference in the rate between the two groups was 4.2% (95% confidence interval, -2.7 to 11.0), which demonstrated the non-inferiority of IV LVFX to IV PZFX. One of the secondary endpoints was the efficacy rate in terms of the microbial eradication rate at 5 to 9 days after completion of the oral LVFX treatment period. The efficacy rate was 76.2% (96/126) in the LVFX/LVFX group and 79.7% (98/123) in the PZFX/LVFX group; the difference in the rate between the two groups was -3.5% (95% confidence interval, -13.8 to 6.8). The incidence of adverse drug reactions was 34.6% (56/162) in the LVFX/LVFX group and 32.1% (52/162) in the PZFX/LVFX group; the difference in the rate between the two groups was 2.5% (95% confidence interval, -7.8 to 12.7).
These results showed that IV LVFX administered at the dose of 500 mg once daily was comparable in the efficacy and safety to IV PZFX administered at the dose of 500 mg twice daily, and sequential IV/oral LVFX is useful for the treatment of adult hospitalized patients with urinary tract infections.
Key word
levofloxacin, urinary tract infection, pyelonephritis, complicated cystitis
Received
June 28, 2016
Accepted
July 29, 2016
Jpn. J. Chemother. 64 (6): 796-812, 2016
