Comparative, double-blind, prospective, multicenter trial of temafloxacin versus trimethoprim-sulfamethoxazole in uncomplicated urinary tract infections in women.

In a double-blind, randomized, multicenter study, 400 women with symptoms of acute urinary tract infections were treated with either a 7-day course of temafloxacin hydrochloride (400 mg once a day; n = 204) or a 10-day course of trimethoprim (160 mg) and sulfamethoxazole (800 mg) (TMP-SMZ) twice daily (n = 196). The bacteriologic cure rates at 5 to 9 days posttherapy were 100% in the temafloxacin group and 97% in the TMP-SMZ group (P = 0.035). The clinical cure rates were 93% in the temafloxacin group and 95% in the TMP-SMZ group (P greater than 0.1). Adverse events, including nausea, vomiting, rash, headache, and dizziness, were experienced by 19.6% of the temafloxacin group and 23.5% of the TMP-SMZ group. Transient leukopenia occurred in 0.5 and 4.1% of the temafloxacin and TMP-SMZ groups, respectively. Temafloxacin, 400 mg once a day for 7 days, appears to be at least as safe and effective as a 10-day course of TMP-SMZ in the management of acute urinary tract infection in women.