Comparison of once-daily extended-release ciprofloxacin and conventional twice-daily ciprofloxacin for the treatment of uncomplicated urinary tract infection in women

摘要: Abstract Background: Trimethoprim/sulfamethoxazole (TMP/SMX) is currently the first choice for empiric therapy of acute uncomplicated urinary tract infection (UTI) in women. In areas where resistance to TMP/SMX known be high, ciprofloxacin and other fluoroquinolones are recommended as first-line choices UTI. Objective: This study compared efficacy safety profile once-daily extended-release 500 mg (referred hereafter QD) with those conventional 250 BID, each administered orally 3 days, treatment UTI Methods: this multicenter, prospective, randomized, double-blind, double-dummy, Phase III trial, adult women clinical signs symptoms UTI, pyuria, a positive pretherapy urine culture (≥10 5 colony - forming units / mL ) received QD or BID. Bacteriologic outcomes were assessed at test-of-cure visit (4–11 days after completion therapy) late follow-up (25–50 therapy). Results: The intent-to-treat population consisted 891 patients (444 QD, 447 BID); 422 evaluable (199 223 BID). At visit, bacteriologic eradication was achieved 94.5% (188/199) group 93.7% (209/223) BID (95% CI, −3.5 5.1). Clinical cure 95.5% (189/198) 92.7% (204/220) −1.6 7.1). consistent findings. rate Escherichia coli , most prevalent organism, >97% group. Rates drug-related adverse events similar once- twice-daily regimens (10% 9%, respectively). Conclusion: Extended-release given once daily effective well tolerated twice