Oral temafloxacin compared to norfloxacin for the treatment of complicated urinary tract infections.

Temafloxacin is a new oral fluoroquinolone with broad-spectrum antimicrobial activity against gram-negative and gram-positive pathogens. The safety and efficacy of temafloxacin were evaluated in a multicenter, double-blind study of patients with complicated urinary tract infections. Patients were randomized to receive temafloxacin 400 mg (n = 138) or norfloxacin 400 mg (n = 141). Treatment was given orally twice daily for 10-14 days. Clinical response (cure or improvement) occurred in 75 of 78 patients (96%) in the temafloxacin group and in 89 of 91 patients (98%) in the norfloxacin group. Bacteriologic eradication rates in both treatment groups exceeded 95%. Adverse events occurred in a similar, low percentage of patients in both treatment groups and consisted primarily of nausea and dizziness. Temafloxacin appears to be as safe and effective as norfloxacin in the treatment of complicated urinary tract infections.