Vol.56 No.S-1 April 2008
Clinical study of sitafloxacin in the treatment of male gonococcal urethritis
1)Department of Infection Control, Jikei University Affiliated Hospital, 3-19-18 Nishishinbashi, Minato-ku, Tokyo, Japan
2)Department of Pharmacology, Jikei University School of Medicine
Abstract
The clinical efficacy and safety of sitafloxacin(STFX), a new quinolone compound, were evaluated in male patients with gonococcal urethritis by preliminary study. STFX was orally administered at a single dose of 200 mg. Clinical efficacy was evaluated based on the criteria for evaluation of clinical efficacy of antimicrobial agents on urinary tract infection (draft, fourth edition).
Overall clinical efficacy was 75.0% (9/12) in gonococcal urethritis. The range of MICs of STFX against 12 Neisseria gonorrhoeae isolates from this study was ≤0.001 to 0.25 μg/mL, and MICs of 3 isolates were 0.25 μg/mL. Overall eradication was 75.0% (9/12) for N. gonorrhoeae. Eradication by MICs was 100% (8/8) with MIC of ≤0.06 μg/mL, and 25.0% (1/4) with MIC of ≥0.12 μg/mL.
MICs of ciprofloxacin against 7 of 12 isolates were ≥1 μg/mL. These 7 isolates had amino acid substitutions in quinolone-resistance-determining regions of GyrA and ParC. Four of 7 strains with quinolone resistance were eradicated. Adverse reactions occurred in 25.0% (3/12) of cases evaluable for safety. Adverse reactions involved diarrhea, headache, and blood bilirubin increase in one case each. All symptoms were mild.
Results suggest that STFX at a single dose of 200 mg is inadequate in dosage for eradicating quinolone-resistant N. gonorrhoeae, but safe in the treatment of male gonococcal urethritis.
Key word
sitafloxacin, gonococcal urethritis, quinolone-resistance, clinical trial
Received
November 2, 2007
Accepted
December 28, 2007
Jpn. J. Chemother. 56 (S-1): 146-153, 2008
