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 > 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.Temafloxacin hydrochloride is a new fluoroquinolone with a broad spectrum of activity in vitro against both gramnegative and gram-positive uropathogens (12,13,24,25). The in vitro activity of temafloxacin is comparable to those of ofloxacin and ciprofloxacin (13,14). Pharmacokinetic studies indicate that temafloxacin has good gastrointestinal absorption, with complete dose linearity and a half-life in plasma of approximately 8 h (23). The volume of distribution of temafloxacin is high because of significant intracellular penetration and concentration. The major route of elimination is by urinary excretion, with approximately 60% of a dose being excreted in the urine in its active form (26). The high levels of drug in plasma, tissue, and urine are well above the MIC for most urinary pathogens (23,26). Temafloxacin is well tolerated and is generally devoid of serious adverse effects (26-28). The favorable pharmacokinetic characteristics and antibacterial activity make temafloxacin a suitable antimicrobial agent for once-a-day use in the treatment of urinary tract infection (UTI).In this double-blind, randomized, multicenter trial, the safety and efficacy of a 7-day course of temafloxacin (400 mg once daily) was compared with a 10-day course of trimethoprim-sulfamethoxazole (TMP-SMZ; 160/800 mg twice daily) in the treatment of UTI in women. TMP-SMZ was chosen as the control regimen because of its established safety and efficacy and its wide use in the treatment of UTI (1, 3-5, 8, 10, 14, 17).
MATERIALS AND METHODSPatient selection. Four hundred women from 28 study sites nationwide (see below) were enrolled in the study. All patients were age 18 or older and had symptoms of acute UTI. The criteria for inclusion were as follows: (i) symptoms of UTI, e.g., dysuria, frequency, and urgency; (ii) pyuria (>5 leukocytes per high-power field); and (iii) bacteriuria, with at least 105 CFU (per ml) of one or two pathogens not resistant to the study agents found on microscopic examination of urine sediment within 48 h prior to treatment. Patients had to meet al...