Sequential intravenous/oral ciprofloxacin as an empiric antimicrobial therapy: results of a Canadian multicenter study. The Canadian Collaborative Investigational Group.
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abstract
An open-label, nonrandomized, multicenter study was designed to evaluate the efficacy and safety of intravenous (i.v.) ciprofloxacin, followed by oral ciprofloxacin and/or some other antimicrobial, as presumptive (empiric) therapy in hospitalized patients with clinical and bacteriologic evidence of infection. Out of a total of 149 patients recruited by 31 physician investigators, 148 were assessable for the determination of clinical efficacy and 102 patients were assessable for bacteriologic efficacy. All 149 patients were included in the evaluation of the safety of i.v. ciprofloxacin. The mean duration of IV ciprofloxacin therapy was 6 days, and 111 patients were subsequently switched to oral treatment with ciprofloxacin and/or some other antimicrobial. A clinically favorable response was achieved using i.v. ciprofloxacin in 48 (75%) of 64 patients with pneumonia; 4 (80%) of 5 patients with other lower respiratory tract infection (LRTI); 21 (88%) of 24 patients with pyelonephritis; all 7 (100%) patients with complicated cystitis; 16 (94%) of 17 patients with other complicated urinary tract infection (UTI); all 8 (100%) patients with cellulitis; both (100%) patients with infected ulcer; 4 (80%) of 5 patients with other skin or skin structure infection; 5 (83%) of 6 patients with bone infections; all 8 (100%) patients with septicemia; the 1 (100%) patient with acute cholecystitis; and the 1 (100%) patient with liver abscess. Of the 88 patients from these infection categories who were switched to oral ciprofloxacin, only 2 patients (2.3%) were classified as a clinical failure at the end of all therapy. Eradication of the causative pathogen was demonstrated with i.v. ciprofloxacin in 18 (55%) of 33 assessable patients with pneumonia; 1 (25%) of 4 patients with other LRTI; 17 (81%) of 21 patients with pyelonephritis; 3 (43%) of 7 patients with complicated cystitis; 9 (69%) of 13 patients with other complicated UTI; 3 (60%) of 5 patients with cellulitis; neither (0%) of the 2 patients with infected ulcer; 3 (50%) of 6 patients with other skin or skin structure infection; 2 (33%) of 6 patients with bone infections; and 4 (80%) of 5 patients with septicemia. A causative pathogen was not isolated in the 1 patient with liver abscess; initial bacteriologic culture was not available for the patient with acute cholecystitis. Of the 56 bacteriologically assessable patients from these infection categories who were switched to oral ciprofloxacin, there were only 3 patients (5.4%) in whom the causative bacterial pathogens were not successfully eradicated at the end of all therapy. There were no unexpected adverse events with the use of i.v. ciprofloxacin.(ABSTRACT TRUNCATED AT 400 WORDS)
