Randomised double-blind study of norfloxacin and cefadroxil in the treatment of acute pyelonephritis

Abstract

In a coordinated, double-blind multi-centre trial, adults with symptoms of acute pyelonephritis were randomly assigned to receive a two-week course of oral treatment with either 400 mg norfloxacin twice daily or 1 g cefadroxil twice daily. Of 197 patients enrolled in the study, 140 could be evaluated for drug efficacy and 193 for drug safety. Norfloxacin gave a significantly higher bacteriological cure rate than cefadroxil, both at 3 to 10 days (98 % versus 65 %; p<0.0001; 95 % confidence interval (CI) for difference in proportions 21–46 %) and up to eight weeks (87 % versus 48 %; p<0.0001; 95 % CI 25–54 %) after cessation of treatment. The differences between the two regimens were most pronounced in men and in patients with complicating factors such as diabetes mellitus and urinary tract abnormalities. The clinical response during treatment did not differ between the two groups, but symptomatic recurrences at follow-up were more common in the cefadroxil group (28 % versus 3 %; p<0.0001; 95 % CI 14–36 %). Adverse events were more often reported by patients receiving cefadroxil (39 % versus 22 %; p=0.011; 95 % CI 4–30 %) and consisted mainly of gastrointestinal disturbances and vulvo-vaginitis. In terms of bacteriological and clinical efficacy and safety, a two-week course of norfloxacin was superior to a two-week course of cefadroxil for oral treatment of community-acquired acute pyelonephritis.