Vol.65 No.3 May 2017
A phase III study of sequential intravenous/oral levofloxacin in adult patients with acute bacterial prostatitis or acute epididymitis
1)Department of Urology, University of Occupational and Environmental Health, Japan, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan
2)Department of Urology, Gifu University Hospital
3)Department of Urology, Hyogo College of Medicine
4)Ito Urology Clinic
5)Kawahara Nephro-Urological Clinic
6)Kawahara Urology Clinic
7)iClinic
8)Hara Genitourinary Hospital
9)R&D Division, Daiichi Sankyo Co., Ltd.
10)Professor emeritus, University of Occupational and Environmental Health, Japan
Abstract
Purpose: This study was a multicenter phase III study to evaluate the efficacy and safety of sequential intravenous/oral levofloxacin (LVFX) 500 mg to patients with acute bacterial prostatitis or acute epididymitis.
Material and methods: The subjects were patients with acute bacterial prostatitis or acute epididymitis and were administered LVFX 500 mg by intravenous injection once a day for 3 to 7 days, followed by oral LVFX 500 mg once a day for 11 to 14 days. The efficacy of the levofloxacin regimen was evaluated according to the Japanese Guideline for Clinical Research of Antimicrobial Agents on Urogenital Infections (the first edition).
The primary endpoint of microbiological efficacy was the microbial eradication rate at 5 to 9 days after the completion of the oral LVFX treatment period.
Results: The microbiological eradication rate was 83.3% (5/6) in the patients with acute bacterial prostatitis, and 83.3% (5/6) in the patients with acute epididymitis. The clinical efficacy rate at 5 to 9 days after completion of the oral LVFX treatment period was 83.3% (5/6) in the patients with acute bacterial prostatitis, and 66.7% (4/6) in the patients with acute epididymitis. The incidence rates of adverse events and adverse drug reactions (ADRs) were 38.9% (7/18) and 22.2% (4/18), respectively. The ADRs were mild and recovered without special treatments.
Conclusion: The sequential intravenous/oral therapy with LVFX 500 mg once a day is effective and safe against acute bacterial prostatitis and acute epididymitis.
Key word
levofloxacin, acute bacterial prostatitis, acute epididymitis
Received
October 18, 2016
Accepted
January 12, 2017
Jpn. J. Chemother. 65 (3): 484-490, 2017