The clinical and bacteriologic efficacy of 3 days of cefcanel daloxate therapy, compared with 3 days of amoxicillin for the treatment of acute uncomplicated urinary tract infection was compared in a prospective randomized double-blind multicentre study. 400 subjects were randomized to receive cefcanel daloxate and 199 to receive amoxicillin. 166 (77%) of 215 evaluable cefcanel daloxate subjects and 72 (77%) of 94 evaluable amoxicillin subjects evidenced bacteriologic elimination at short-term follow-up, while in 149 (69%) and 67 (71%), respectively, clinical symptoms disappeared. At long-term follow-up, 150 (70%) cefcanel daloxate and 65 (69%) amoxicillin subjects evidenced bacteriological elimination, while in 150 (70%) and 61 (65%), clinical symptoms disappeared. There were no significant differences in outcome between the 2 therapeutic regimens. Adverse events were similar in the 2 groups. In additional analyses, antimicrobial efficacy diminished significantly with increasing age, pretherapy in vitro susceptibility was significantly associated with bacteriological failure at the short-term visit, and subjects with low quantitative counts pretherapy had clinical outcomes similar to those with quantitative counts > or = 10(5) cfu/ml at the short-term outcome. These data suggest that cefcanel daloxate and amoxicillin are comparable as regards efficacy and adverse effects for 3-day therapy of acute uncomplicated urinary tract infection. The observed cure rates, however, are lower than those reported for other agents such as trimethoprim/sulfamethoxazole or quinolones for short course therapy.