Cefdinir versus cefaclor in the treatment of uncomplicated urinary tract infection

Objective: This multicenter, double-blind, randomized, parallel-group study was conducted in Europe, South Africa, and Australia to compare the clinic al and microbiologic efficacy and the tolerability of a cephalosporin antib iotic, cefdinir, with those of cefaclor in the treatment of uncomplicated u rinary tract infection. Methods: Patients were randomized in a 1:1 ratio to 5 days of treatment wit h either cefdinir 100 mg BID or cefaclor 250 mg TID. Results: 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 symp toms on admission. The most frequently isolated pathogens in admission urin e cultures were Escherichia coli (383 patients), Proteus mirabilis (20 pati ents), Staphylococcus saprophyticus (14 patients), and Klebsiella pneumonia e (9 patients). Of the admission pathogens with documented susceptibility r esults, significantly more were resistant to cefaclor (6.7%) than to cefdin ir (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 18 7 in the cefaclor group, Clinical cure rates and microbiologic response rat es for cefdinir and cefaclor were statistically equivalent at 5 to 9 days p osttherapy (test-of-cure visit), using a 95% CI approach. The rate of treat ment-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 gr eater frequency of diarrhea in the former group. However, only 4 patients ( 1.2%) discontinued cefdinir treatment due to diarrhea. Conclusion: Empiric therapy with cefdinir appears to be a reasonable choice for patients with uncomplicated urinary tract infection in whom cephalospo rin treatment is indicated.