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)