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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
[Efficacy of single dose of ciprofloxacin and pefloxacin in the treatment of female acute cystitis].
- J Guibert.
- Hôpital Saint-Joseph, Paris.
- Presse Med. 1995 Feb 11; 24 (6): 304-8.
ObjectivesA multicentric double-blind double-placebo randomized trial was conducted to compare the effectiveness and safety of ciprofloxacin versus pefloxacin given in a single oral dose in female out-patients with acute cystitis.MethodsA series of 561 female patients (age range 18-65 years) with signs of uncomplicated community acquired acute cystitis were randomly assigned to parallel groups given a single oral dose of ciprofloxacin (500 mg + placebo) or pefloxacin (800 mg + placebo). Clinical and bacteriological effectiveness was evaluated 12 +/- 2 days after the treatment day.ResultsThe clinical outcome was equivalent for the two groups (92 vs 88.9% clinical cure for ciprofloxacin and pefloxacin respectively). Mean time to clinical resolution was about 40 hours in both groups. Urine sterilization was comparable in the two groups (80.8 and 81.1% respectively). Undesirable side effects (mostly digestive tract disorders and neurosensorial complaints) were reported in 16.1% of the patients taking ciprofloxacin and 18.1% of those taking pefloxacin (NS). Single-dose treatment was well accepted by 82.3 and 84.8% of the women respectively.ConclusionThese findings demonstrate that ciprofloxacin and pefloxacin are equally effective and equally well tolerated as single-dose oral curative therapy for acute cystitis in women.
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