BACKGROUND--This study was undertaken to determine whether
therapy for acute uncomplicated
urinary tract infection in women with single-dose
therapy with
norfloxacin was superior to 3 days of
norfloxacin therapy in efficacy or adverse effects. METHODS--The study was a multicenter, prospective, randomized, double-blind trial. Women with acute, uncomplicated
urinary tract infection were randomized to receive
norfloxacin, 800 mg as a single dose or 400 mg twice daily for 3 days. Clinical and laboratory evaluations were obtained before
therapy and at days 3 and 7 and 4 to 6 weeks after initiation of
therapy. RESULTS--The 83 subjects for whom data could be evaluated who received 3-day
therapy had significantly improved outcome compared with the 73 subjects for whom data could be evaluated who received single-dose
therapy at 3 days and 7 days after initiation of
therapy. At 4 to 6 weeks, 88% of subjects who received 3 days of
therapy remained cured, compared with 78% who received single-dose
therapy. Three-day and single-dose
therapy were equivalent for
Escherichia coli infection, but single-dose
therapy was significantly less effective for other organisms, primarily because of failure of treatment of Staphylococcus saprophyticus
infection. Women older than 40 years were significantly less likely to be cured with either treatment regimen and with single-dose
therapy. Adverse effects were similar for both treatment regimens.
CONCLUSIONS: