A randomized, double-blind, multicenter comparison of gatifloxacin versus ciprofloxacin in the treatment of complicated urinary tract infection and pyelonephritis.
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BACKGROUND
Gatifloxacin is a fluoroquinolone antibiotic with a broad spectrum of in vitro and in vivo activity against the gram-negative and gram-positive pathogens frequently implicated in urinary tract infections (UTIs).
OBJECTIVE
This study compared the clinical and bacteriologic efficacy and tolerability of gatifloxacin versus ciprofloxacin in adult patients with complicated UTIs or pyelonephritis.
METHODS
In this double-blind, multicenter, randomized, comparative study, patients were treated with either gatifloxacin 400 mg once daily or ciprofloxacin 500 mg twice daily for 7 to 10 days. Bacteriologic eradication (by quantitative urine culture) and clinical efficacy rates were assessed at a test-of-cure visit (5 to 9 days and 4 to 11 days posttreatment, respectively) and at an extended follow-up visit (29-42 days and 25-50 days posttreatment, respectively).
RESULTS
A total of 372 adults were randomized to treatment, 189 to gatifloxacin and 183 to ciprofloxacin. The most commonly isolated pretreatment pathogens (n = 292) were Escherichia coli (53%) and Klebsiella pneumoniae (13%). Pathogen eradication rates for complicated UTIs were 92% and 83% with gatifloxacin and ciprofloxacin, respectively (95% CI, -4.1% to 24.5%); for pyelonephritis, the respective rates were 92% and 85% (95% CI, -20% to 37%). Clinical response rates of >90% were observed in both treatment groups among patients with complicated UTIs as well as those with pyelonephritis. Sustained eradication rates were 76% (64/84) with gatifloxacin and 66% (52/79) with ciprofloxacin. Both drugs were well tolerated, with the most common adverse events in both treatment groups being nausea, dizziness, diarrhea, and vomiting.
CONCLUSIONS
Gatifloxacin is comparable to ciprofloxacin based on clinical efficacy and bacteriologic eradication rates for the treatment of complicated UTIs or pyelonephri- tis and is associated with a low incidence of clinically significant adverse events.
