Ciprofloxacin: an update on clinical experience.

This report presents the results of 146 clinical trials of the oral form of ciprofloxacin, a new quinolone antimicrobial agent active against a broad spectrum of gram-negative and gram-positive organisms, including Pseudomonas aeruginosa and methicillin-resistant strains of staphylococci. The safety of ciprofloxacin was assessed in 2,829 patients, most of whom were treated in the United States, and the analysis of efficacy was based on data from 3,981 patients evaluated through June 1986. In general, the patients received ciprofloxacin at a dosage of 250 to 750 mg every 12 hours; the median dose was 500 mg twice daily. Dose-ranging studies in male patients with urinary tract infections indicated that a regimen of 500 or 750 mg twice daily was not substantially more effective than a regimen of 250 mg twice daily. Forty-four double-blind, controlled trials were conducted to compare the efficacy and safety of oral ciprofloxacin with those of standard therapeutic agents in the treatment of infections of the urinary tract, skin and skin structure, respiratory tract, and bone. Ciprofloxacin at 250 mg twice daily was as effective as trimethoprim/sulfamethoxazole at 160/800 mg twice daily in the treatment of urinary tract infections. Orally administered ciprofloxacin in a regimen of 750 mg twice daily was shown to be as effective as cefotaxime administered intravenously at 2 g three times daily in the treatment of infections of the skin and skin structure. When compared with ampicillin for the treatment of respiratory tract infections, ciprofloxacin was as effective in resolving or improving markedly the signs and symptoms of infection and eradicated a higher percentage of causative organisms. Adverse reactions considered probably or possibly related to the drug were reported for 16.2 percent of the patients treated; most were of only mild or moderate intensity and resolved after therapy was completed. Emergence of resistant organisms associated with ciprofloxacin therapy has been reported infrequently.