ONCE-DAILY FLEROXACIN VERSUS TWICE-DAILY CIPROFLOXACIN IN TREATMENT OF COMPLICATED URINARY-TRACT INFECTIONS

Purpose: We compared the efficacy and safety of once-daily fleroxacin and twice-daily ciprofloxacin in patients with complicated urinary tra ct infections. Materials and Methods: Using a prospective, open, rando mized, multicenter study design, 133 patients (67 fleroxacin, 66 cipro floxacin) were treated with doses of either 200 mg, of fleroxacin once daily or 250 mg. of ciprofloxacin twice daily in phase 1. In phase 2, 211 patients (103 fleroxacin, 108 ciprofloxacin) received 400 mg, of fleroxacin once daily or 500 mg. of ciprofloxacin twice a day. Results : In phase 1, bacteriological efficacy was excellent only against sens itive pathogens, such as Escherichia coli (84% with flexoxacin, 88% wi th ciprofloxacin), but high failure rates were observed in infections caused by Pseudomonas species (56% with fleroxacin, 67% with ciproflox acin) and gram-positive organisms (52% with fleroxacin, 67% with cipro floxacin). In phase 2, bacteriological overall success rate was 88% in the fleroxacin group and 84% in the ciprofloxacin group. Clinical ove rall success was observed in more than 90% of patients in both groups (94% with fleroxacin, 93% with ciprofloxacin). No statistically signif icant differences between the drugs were observed in efficacy during p hase 2, including a 4 to-6-week followup. Tolerance was also similar f or fleroxacin and ciprofloxacin, with about 20% of patients reporting adverse events. Conclusions: The results suggest that both fleroxacin and ciprofloxacin are safe and effective for the treatment of complica ted urinary tract infections at the higher doses used in phase 2, with fleroxacin offering the advantage of a once-daily dosing regimen. Low er doses of fleroxacin (200 mg. once daily) should only be used to tre at urinary tract infections caused by gram-negative organisms with min imum inhibiting concentrations of less than 0.5 mg./l.