Comparison of three-day temafloxacin with seven-day ciprofloxacin treatment of urinary tract infections in women.
BACKGROUND
Temafloxacin is a new broad-spectrum arylfluoroquinolone antimicrobial with an extended serum half-life.


METHODS
In this large, multicenter, double-blind clinical trial, 404 women with acute, uncomplicated urinary tract infections (UTI) were randomized to receive temafloxacin 400 mg once daily for 3 days, or ciprofloxacin 250 mg twice daily for 7 days. Clinical and microbiologic evaluations were repeated at 4 to 5 days after initiation of treatment, at the end of therapy, and at 5 to 9 days posttreatment. One hundred fifteen patients who received temafloxacin and 105 patients who received ciprofloxacin met the eligibility criteria for efficacy evaluation. The predominant urinary pathogens were Escherichia coli, Proteus mirabilis, and coagulase-negative staphylococci. No pretherapy isolate was resistant to either study drug.


RESULTS
Bacteriologic eradication was observed in 112 (97%) of 115 women treated with temafloxacin and 101 (96%) of 105 women treated with ciprofloxacin. Clinical cure rates at 5 to 9 days posttreatment were 90% (the remaining 10% improved) with temafloxacin and 95% (the remaining 5% improved) with ciprofloxacin. Adverse effects associated with treatment occurred in 24 (12%) women who received temafloxacin and 31 (15%) women who received ciprofloxacin. Headache (2% with temafloxacin and 2% with ciprofloxacin), nausea (3% with temafloxacin and 6% with ciprofloxacin), and somnolence (4% with temafloxacin and 3% with ciprofloxacin) were reported most often. Only three and five patients who were treated with temafloxacin and ciprofloxacin, respectively, discontinued treatment because of adverse effects.


CONCLUSIONS
In this study, a 3-day treatment regimen using a single daily 400-mg dose of temafloxacin was found to be as effective as a 7-day course of ciprofloxacin in women with acute uncomplicated UTI.
Stein
G E
GE
Department of Medicine, Michigan State University, East Lansing 48824.
Philip
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D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D002939:Ciprofloxacin / Q000627:therapeutic use*; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008875:Middle Aged; D015363:Quinolones / Q000627:therapeutic use*; D014552:Urinary Tract Infections / Q000188:drug therapy*
D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D015363:Quinolones; C054745:temafloxacin; D002939:Ciprofloxacin