Comparative efficacy of sparfloxacin versus ciprofloxacin in the treatment of complicated urinary tract infection.
A total of 686 adult patients with complicated urinary tract infections were enrolled in a double-blind, randomised, multicentre study to compare sparfloxacin (200 mg loading dose on day 1 followed by 100 mg daily) with ciprofloxacin (500 mg orally twice daily) for 10 to 14 days. Urinary tract infection was defined as pyuria and bacteriuria (cfu > or = 10(5)/mL). Evaluations were performed at four time-points. The clinical efficacy of the two antibacterial agents was equivalent at the end of treatment: clinical cure in 88.6% of the intent-to-treat population and 87.3% in the evaluable population treated with sparfloxacin compared to 85.4% and 84.8% of the intent-to-treat and evaluable populations, respectively, treated with ciprofloxacin. The clinical results were also equivalent at follow-up. The bacteriological efficacy of the two agents was not equivalent. At the end of treatment, bacteriological cure was observed in 72.6% of the intent-to-treat and 72.1% of the evaluable populations treated with sparfloxacin and in 81.4% and 80.8% of the intent-to-treat and evaluable populations, respectively, treated with ciprofloxacin. The difference was primarily because of a higher number of persisting pathogens, which included Enterobacteriaceae other than Escherichia coli, Pseudomonas aeruginosa and enterococci, which exhibited moderate susceptibility to sparfloxacin. Tolerability was similar in the two treatment groups.
Naber
K G
KG
Urologic Clinic, Elisabeth Hospital, Straubing, Germany.
di Silverio
F
F
Geddes
A
A
Guibert
J
J
D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002939:Ciprofloxacin / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004927:Escherichia coli Infections / Q000188:drug therapy / Q000652:urine; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D014552:Urinary Tract Infections / Q000150:complications / Q000188:drug therapy*
D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D015363:Quinolones; D002939:Ciprofloxacin; C061363:sparfloxacin