Clinical study of sitafloxacin in the treatment of male gonococcal urethritis

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  • Onodera Shoichi
    Department of Infection Control, Jikei University Affiliated Hospital
  • Hori Seiji
    Department of Pharmacology, Jikei University School of Medicine

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  • 男子淋菌性尿道炎を対象としたsitafloxacinの一般臨床試験

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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).<BR>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 0.25μg/mL, and MICs of 3 isolates were 0.25μg/mL. Overall eradication was 75.0%(9/12) for N. gonorrhoeae. Eradication by MICs was 100%(8/8) with MIC of≤0.06 p emL, and 25.0%(1/4) with MIC of≤0.12μg/mL.<BR>MICs of ciprofloxacin against 7 of 12 isolates were≤1μg/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.<BR>Results suggest that STFX at a single dose of 200 mg is inadequate in dosage for eradicating quinoloneresistant N. gonorrhoeae, but safe in the treatment of male gonococcal urethritis.

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