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Single-dose oral ciprofloxacin compared with cefotaxime and placebo for prophylaxis during transurethral surgery.

Abstract
To determine the efficacy and safety of single-dose oral ciprofloxacin prophylaxis for the prevention of post-operative bacteriuria following transurethral resection of the prostate or bladder tumour, a prospective, randomized, double-blind, placebo-controlled trial was conducted. Five hundred and eighteen patients were randomized in a 2:2:1 ratio to receive ciprofloxacin 500 mg, cefotaxime 1 g or placebo 30-90 min before surgery. Of the 368 efficacy-evaluable patients, five (3.3%) ciprofloxacin, seven (4.8%) cefotaxime and five (7.0%) placebo recipients had post-operative bacteriuria (> or = 10(4) cfu/mL) during post-operative days 2-15. Five (3.4%) ciprofloxacin, five (3.4%) cefotaxime and one (2.4%) placebo recipients were considered clinical failures, of whom one, two and one patients, respectively, had concomitant bacteriuria. Drug-related adverse events were reported in six of 204 (3%) ciprofloxacin, 12 of 197 (6%) cefotaxime and one of 101 (1%) placebo patients. The observed rates of post-operative bacteriuria suggest that a single 500 mg dose of ciprofloxacin is suitable prophylaxis for transurethral surgery.
AuthorsI W Klimberg, G H Malek, C E Cox, A L Patterson, E Whalen, S F Kowalsky, R M Echols
JournalThe Journal of antimicrobial chemotherapy (J Antimicrob Chemother) Vol. 43 Suppl A Pg. 77-84 (Mar 1999) ISSN: 0305-7453 [Print] England
PMID10225576 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Infective Agents
  • Cephalosporins
  • Placebos
  • Ciprofloxacin
  • Cefotaxime
Topics
  • Administration, Oral
  • Adult
  • Aged
  • Anti-Infective Agents (therapeutic use)
  • Bacteriuria (prevention & control)
  • Cefotaxime (therapeutic use)
  • Cephalosporins (therapeutic use)
  • Ciprofloxacin (therapeutic use)
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Placebos
  • Prostatectomy (adverse effects)

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