Vol.52 No.6 June 2004

Comparative study of cefcapene pivoxil and levofloxacin in complicated urinary-tract infections Evaluated using UTI Drug Efficacy Evaluation Standards (4^th Edition)

Takashi Matsui¹⁾, Soichi Arakawa²⁾, Gaku Kawabata²⁾, Kazushi Tanaka²⁾, Kazuma Yoshiyuki²⁾, Sadao Kamidono²⁾, Toshihiko Mita³⁾, Nobuo Kataoka⁴⁾, Osamu Matsumoto⁵⁾, Nobutoshi Oka⁶⁾, Hiroshi Ohmae⁶⁾, Masuo Yamashita⁷⁾, Akira Fujii⁸⁾, Shigenori Miyazaki⁹⁾, Shinichi Morishita¹⁰⁾, Hiroshi Yamazaki¹¹⁾ and Masayuki Kuwayama¹²⁾

¹⁾Department of Urology, Takasago Municipal Hospital,
33-1 Kami-machi, Arakawa-cho, Takasago, Hyogo, Japan
²⁾Department of Urology, Kobe University, School of Medicine
³⁾Mita and Terasoma Urological clinic
⁴⁾Department of Urology, Nishiwaki City Hospital
⁵⁾Department of Urology, Miki City Hospital
⁶⁾Hara Urological Hospital
⁷⁾Department of Urology, Akashi City Hospital
⁸⁾Department of Urology, Nippon Steel Hirohata Hospital
⁹⁾Department of Urology, Sanda City Hospital
¹⁰⁾Department of Urology, Kanebo Memorial Hospital
¹¹⁾Department of Urology, Kobe Rosai Hospital
¹²⁾Department of Urology, Shisoo General Hospital

Abstract

To evaluate the efficacy of the oral cephem antibiotic cefcapene pivoxil (CFPN-PI) against complicated noncatheterized urinary-tract infections, we conducted a comparative study by the envelope method using the quinolone antibiotic levofloxacin (LVFX), as the comparative drug. Both drugs were administered at 100 mg per dose 3 times a day for 7 days. Clinical efficacy was evaluated based on the UTI Drug Efficacy Evaluation Standards (4^th edition). No significant difference in background factors was seen between groups.
In early-phase evaluation, overall clinical efficacy was 84.4% among 32 cases in the CFPN-PI administration group and 86.1% among 36 cases in the LVFX administration group.
When late-phase microbiological outcome was evaluated 1 week after the completion of administration, 66.7% was judged "eradicated" and 33.3% "failed" among 27 cases in the CFPN-PI group and 81.5% "eradicated" and 24.1% were judged "eradication" and "failed" among 29 cases in the LVFX group.
When the microbiological outcome was evaluated for healing at 1 month after the completion of administration, 76.4% was judged "eradicated" and 23.1% "failed" among 13 cases in the CFPN-PI group and 58.3% "eradicated" and 41.7% "failed" among 12 cases in the LVFX group. No significant difference was seen between groups in any evaluations.
Side effects were observed in 1 of 77 cases (1.3%) in the CFPN-PI group and in 3 of 75 cases (4.0%) in the LVFX administration group, with no significant difference between groups.
CFPN-PI thus showed effects similar to LVFX and was found to be useful against bacterial strains adopted in complicated noncatherized urinary-tract infection when treatment outcomes for healing at 1 month was evaluated as the endpoint using UTI Drug Efficacy Standards (4^th Edition).

Key word

cefcapene pivoxil, levofloxacin, control study

Received

March 25, 2004

Accepted

May 21, 2004

Jpn. J. Chemother. 52 (6): 318-329, 2004