Vol.62 No.4 July 2014

Clinical efficacy of sitafloxacin, 200 mg daily for 3 days, against female patients with acute uncomplicated patients; A multi-center trial

Kan Suzuki¹⁾, Haruhisa Koide¹⁾, Shinichiro Kira¹⁾, Jun Moritake¹⁾, Yukiko Hiramoto²⁾, Hiroshi Kiyota¹⁾, Shin Egawa²⁾, Kamon Shimizu³⁾, Chizuru Arisawa⁴⁾, Yasumasa Iimura⁴⁾ and Naoko Kawamura⁴⁾

¹⁾Department of Urology, The Jikei University Katsushika Medical Center, 6-41-2 Aoto, Katsushika-ku, Tokyo, Japan
²⁾Department of Urology, The Jikei University, School of Medicine
³⁾Shimizu Clinic
⁴⁾Department of Urology, Tobu-chiiki Hospital

Abstract

In order to clarify the clinical efficacy of sitafloxacin (STFX) against the female patients with acute uncomplicated cystitis (AUC), we tried 3-day regimen of STFX, 200 mg daily, against 56 female patients with AUC. The clinical efficacy of STFX for AUC was evaluated according to the Japanese guidelines of clinical trial for genitourinary tract infections (1^st Ed, 2011).
As a result, the bacteriological outcome 4-9 days after administration of STFX was 78.6% with eradication in 44 cases, and failure in 12 cases (6 cases with persistence and 6 cases with replaced). Also, the clinical outcome was 96.4% (54 cases with cure, 2 cases with failure). Among 32 cases that were available for recurrent evaluation, bacteriological response rate was 71.9% (23 cases with eradication, positive in 9 cases (relapse in 5 cases and reinfection in 4 cases), and the clinical response rate was 93.8% (30 cases with cure and 2 cases with failure). Thirty-nine of 44 (88.6%) isolated strains of Escherichia coli were eradicated, and MIC₅₀ and MIC₉₀ of STFX were lower than 0.06 μg/mL and 1 μg/mL, respectively. Against 4 strains in 6 persisted strains of E. coli, the MICs of STFX was 1 μg/mL or lower. Sixteen strains of Enterococcus faecalis were isolated, and their sensitivity rate, MIC₅₀ and MIC₉₀ of STFX were 93.8%, 0.12 μg/mL and 0.25 μg/mL, respectively. From these results, the efficacy of STFX against the female patients with AUC due to E. coli was moderately low in this study. Therefore, the longer regimen of STFX might be necessary for AUC.

Key word

sitafloxacin, uncomplicated cystitis, clinical efficacy

Received

March 24, 2014

Accepted

May 12, 2014

Jpn. J. Chemother. 62 (4): 494-500, 2014