Eighty-nine college women with acute urinary tract infections were treated orally with either 1,000 mg of cefuroxime axetil in a single dose (n = 59) or 250 mg of cefaclor three times a day for 7 days (n = 30). At 1 week posttherapy, 88% of the patients in the cefuroxime axetil group and 97% in the cefaclor group were clinically and bacteriologically cured (P > 0.10). There was no statistically significant difference between the cure rates of the two treatment groups. However, this study has only a 50% power to detect a 10% difference. Therefore, there is a substantial possibility of a type II error, i.e., failing to find a difference that is actually present. At 4 weeks posttherapy, 78% of the patients in the cefuroxime group and 80% in the cefaclor group remained cured. By 36 weeks posttherapy, the cumulative rate of recurrence in both treatment groups was 60%. Of the patients with a positive antibody-coated bacteria test, fewer achieved a short-term cure after single-dose treatment with cefuroxime axetil than those with a negative antibody-coated bacteria test (67 versus 96%; P < 0.01).Urinary tract infections (UTIs) are a common medical problem in women (1,12,26,30). They are usually associated with symptoms of cystitis, although the kidneys may be involved (5-7, 11, 23, 41). Single-and multiple-dose regimens of a variety of antimicrobial agents have been reported to be effective in the treatment of these infections in women (15,19,21,33,35). Single-dose antibiotic therapy with simultaneous localization studies of the sites of infection has resulted in favorable responses in patients with infections confined to the bladder and poor responses in those with upper urinary tract involvement or complicated infections (2,10,34,35,38,39,41). Other advantages of single-dose therapy are lower cost, increased patient compliance, fewer adverse effects, and reduced potential for emergence of resistant bacteria in the gut. However, comparisons of long-term recurrence rates between single-dose therapy and conventional multidose therapy are not available.Cephalosporins have a broad spectrum of antimicrobial activity, but their efficacy in single-dose therapy remains controversial (5,14,32,35). The patient population studied, the types of infections, and the pharmacokinetic characteristics of the tested cephalosporin contribute in part to the conflicting results.Cefuroxime axetil was evaluated as a single dose in this clinical study. Cefuroxime is a broad-spectrum, P-lactamase-stable parenteral cephalosporin which is not well absorbed in the gastrointestinal tract, whereas cefuroxime axetil, a novel ester prodrug of cefuroxime, is de-esterified in the intestinal mucosa after oral administration into the active form of cefuroxime and subsequently absorbed to attain effective therapeutic concentrations in plasma and urine (16, 37). The purposes of this trial were (i) to compare the efficacy and safety of a single dose of cefuroxime axetil versus multiple doses of cefaclor for treatment of UTIs, (ii) to relate therapeutic resp...