Clinical study of sitafloxacin in male nongonococcal urethritis

The clinical efficacy and safety of sitafloxacin(STFX), a fluoroquinolone compound, were evaluated in male patients with nongonococcal urethritis treated orally 7 days with 50 mg b.i.d, of STFX. Clinical efficacy was evaluated based on criteria for evaluation of clinical efficacy of antimicrobial agents on urinary tract infection (draft, fourth edition). Overall clinical efficacy was 88.6% (31/35) for nongonococcal urethritis and, by diagnosis, 85.2% (23/27) for nongonococcal-chlamydial urethritis, 100% (7/7) for Mycoplasma genitalium-negative nongonococcal-nonchlamydial urethritis, and excellent in 1 case with M. genitalium-positive nongonococcal urethritis. Eradication by microorganism was 96.0% (24/25) for Chlamydia trachomatis, 88.9% (8/9) for Ureaplasma urealyticum, and 100% (7/7) for Ureaplasma parvum. Two of 3 strains of M. genitalium were eradicated. The incidence of adverse reactions was 27.3% (12/44), the most common being diarrhea. All symptoms were mild or moderate. Results suggest that STFX was effective and safe in the treatment of male nongonococcal urethritis.