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 less than 0.0001; 95% confidence interval (CI) for difference in proportions 21-46%) and up to eight weeks (87% versus 48%; p less than 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 less than 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.

Ceftibuten versus trimethoprim-sulfamethoxazole for oral treatment of febrile urinary tract infection in children

“…Symptomatic recurrences after treatment, however, occurred more frequently among those treated with ceftibuten, which is in agreement with the findings in treatment trials of acute pyelonephritis in women. Thus, recurrent UTI in women were significantly more common after treatment with cefadroxil [15] or ceftibuten [16] than after treatment with TMP-SMX [17] or a fluoroquinolone [15,16]. This result may be attributed to the failure of beta-lactam antibiotics, such as cephalosporins, to eradicate uropathogens from the vaginal or intestinal microflora as compared to TMP-SMX or fluoroquinolones [18].…”

“…Follow-up was scheduled 4-10 days post-treatment (days [14][15][16][17][18][19][20]. The investigator judged the clinical response to treatment, and a urine sample for urinalysis and culture was collected as bag urine or as voided midstream urine.…”

“…The perprotocol (PP) population was derived from the ITT population but included only those patients with bacteria susceptible to the drug they had been allocated to and those who had strictly followed the protocol by taking the trial drug for 10 days, returning for a follow-up visit 4-10 days after the end of treatment (days [14][15][16][17][18][19][20] and delivering a urine sample for culture.…”

Efficacy of a 14-day course of oral ciprofloxacin therapy for acute uncomplicated pyelonephritis

“…However, several studies done in other countries have indicated that an oral agent administered alone, on an outpatient basis, can yield favorable outcomes in the treatment of the disease. 1,2 Fluoroquinolone antimicrobials achieve relatively high serum and urinary concentrations and have strong antibacterial activity against a broad spectrum of bacteria. Thus, the agents have been widely used in the treatment of urinary tract infection.…”

“…In particular, oral fluoroquinolone antibacterial chemotherapy has been reported to be effective for the treatment of acute pyelonephritis. 1,2,4,5 Fluoroquinolone antimicrobials are well known for their broad spectrum of antibacterial activity, as well as for achieving high blood and urinary concentrations. Fluoroquinolones seem to be appropriate for the treatment of urinary tract infection, including acute pyelonephritis, as found in this study.…”