Comparison of sparfloxacin and ciprofloxacin in the treatment of community-acquired acute uncomplicated urinary tract infection in women

Urinary tract infection (UTI) is a common illness, with greater than or equ al to 30% of all women experiencing a UTI during their lifetime. Less than a decade ago, the standard therapy for acute uncomplicated UTIs involved tr eatment with greater than or equal to 7 days of an antibacterial agent, but recent studies using a variety of newly introduced antibiotics, including the fluoroquinolones, have demonstrated that a 1- to 5-day treatment regime n can be equally effective. This randomized, double-masked, multicenter stu dy was conducted to compare the efficacy and tolerability of a single dose of sparfloxacin with those of a 3-day regimen of sparfloxacin and a 7-day r egimen of ciprofloxacin in the treatment of women with community-acquired a cute uncomplicated urinary tract infection. A total of 1175 women were enro lled; 395 received sparfloxacin as a single 400-mg dose on day 1,394 receiv ed sparfloxacin as a 400-mg loading dose on day 1 followed by 200 mg once d aily for 2 additional days, and 386 received ciprofloxacin 250 mg twice dai ly for 7 days. Patients were comparable with respect to demographic charact eristics and underlying conditions. A total of 954 patients were clinically assessable; 490 of these were also bacteriologically assessable. All patie nts treated were included in the tolerability analysis. Escherichia coli (7 5.4%), Klebsiella pneumonine (4.9%), Enterococcus faecalis (4.6%), and Stap hylococcus saprophyticus (4.1%) were the most commonly isolated organisms. In the all-treated population, clinical success was achieved 5 to 9 days af ter therapy in 91.8%, 92.2%, and 91.6% of patients in the single-dose sparf loxacin, 3-day sparfloxacin, and 7-day ciprofloxacin groups, respectively; bacteriologic success was observed in 91.7%, 92.6%, and 96.6% of those in t he 3 groups. Sustained clinical success rates 4 to 6 weeks after therapy we re 76.6%, 80.2%, and 79.5% in the single-dose sparfloxacin, 3-day sparfloxa cin, and 7-day ciprofloxacin groups, respectively; sustained bacteriologic success rates were 80.7%, 90.1%, and 92.6%. The most common adverse events were nausea, headache, vaginal thrush, dizziness, and diarrhea; >92% of adv erse events were mild or moderate in severity. The 2 drugs had comparable f requencies of adverse events, except for photosensitivity, which occurred i n 3.3% of the 3-day sparfloxacin group, 1.3% of the single-dose sparfloxaci n group, and 0.3% of the ciprofloxacin group (P = 0.005). The 3-day sparflo xacin regimen was effective and well tolerated. The initial response to sin gle-dose sparfloxacin treatment was comparable to the response to the other 2 regimens, but the single-dose regimen proved less effective over time, w ith higher rates of clinical recurrence and bacteriologic relapse. Sparflox acin provides an alternative to ciprofloxacin for patients with acute uncom plicated urinary tract infection who are not at risk for photosensitivity r eactions or adverse events associated with a prolonged corrected QT interva l.