Cefdinir versus cefaclor in the treatment of uncomplicated urinary tract infection

This multicenter, double-blind, randomized, parallel-group study was conducted in Europe, South Africa, and Australia to compare the clinical and microbiologic efficacy and the tolerability of a cephalosporin antibiotic, cefdinir, with those of cefaclor in the treatment of uncomplicated urinary tract infection.

Patients were randomized in a 1:1 ratio to 5 days of treatment with either cefdinir 100 mg BID or cefaclor 250 mg TID.

A total of 661 patients were randomized to treatment. They were 90% female, with a median age of 44 years. There were no clinically important differences between groups in terms of demographic characteristics or symptoms on admission. The most frequently isolated pathogens in admission urine cultures were Escherichia coli (383 patients), Proteus mirabilis (20 patients), Staphylococcus saprophyticus (14 patients), and Klebsiella pneumoniae (9 patients). Of the admission pathogens with documented susceptibility results, significantly more were resistant to cefaclor (6.7%) than to cefdinir (3.7%; P < 0.003). Significantly more admission isolates of E. coli were resistant to cefaclor (5.1%) than to cefdinir (2.0%; P < 0.007). A total of 383 patients were assessable for efficacy, 196 in the cefdinir group and 187 in the cefaclor group. Clinical cure rates and microbiologic response rates for cefdinir and cefaclor were statistically equivalent at 5 to 9 days posttherapy (test-of-cure visit), using a 95% CI approach. The rate of treatment-related adverse events was higher in cefdinir-treated patients (20.2%) than in cefaclor-treated patients (13.0%; P = 0.025), mainly due to the greater frequency of diarrhea in the former group. However, only 4 patients (1.2%) discontinued cefdinir treatment due to diarrhea.

Empiric therapy with cefdinir appears to be a reasonable choice for patients with uncomplicated urinary tract infection in whom cephalosporin treatment is indicated.