SEQUENTIAL INTRAVENOUS ORAL CIPROFLOXACIN AS AN EMPIRIC ANTIMICROBIALTHERAPY - RESULTS OF A CANADIAN MULTICENTER STUDY

An open-label, nonrandomized, multicenter study was designed to evalua te the efficacy and safety of intravenous (IV) ciprofloxacin, followed by oral ciprofloxacin and/or some other antimicrobial, as presumptive (empiric) therapy in hospitalized patients with clinical and bacterio logic evidence of infection. Out of a total of 149 patients recruited by 31 physician investigators, 148 were assessable for the determinati on of clinical efficacy and 102 patients were assessable for bacteriol ogic efficacy. All 149 patients were included in the evaluation of the safety of IV ciprofloxacin. The mean duration of IV ciprofloxacin the rapy was 6 days, and 111 patients were subsequently switched to oral t reatment with ciprofloxacin and/or some other antimicrobial. A clinica lly favorable response was achieved using IV 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 pyel onephritis; all 7 (100%) patients with complicated cystitis; 16 (94%) of 17 patients with other complicated urinary tract infection (UTI); a ll 8 (100%) patients with cellulitis; both (100%) patients with infect ed ulcer; 4 (80%) of 5 patients with other skin or skin structure infe ction; 5 (83%) of 6 patients with bone infections; all 8 (100%) patien ts with septicemia; the 1 (100%) patient with acute cholecystitis; and the 1 (100%) patient with liver abscess. Of the 88 patients from thes e infection categories who were switched to oral ciprofloxacin, only 2 patients (2.3%) were classified as a clinical failure at the end of a ll therapy. Eradication of the causative pathogen was demonstrated wit h IV ciprofloxacin in 18 (55%) of 33 assessable patients with pneumoni a; 1 (25%) of 4 patients with other LRTI; 17 (81%) of 21 patients with pyelonephritis; 3 (43%) of 7 patients with complicated cystitis: 9 (6 9%) of 13 patients with other complicated UTI; 3 (60%) of 5 patients w ith 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 wit h liver abscess; initial bacteriologic culture was not available for t he patient with acute cholecystitis. Of the 56 bacteriologically asses sable patients from these infection categories who were switched to or al ciprofloxacin, there were only 3 patients (5.4%) in whom the causat ive bacterial pathogens were not successfully eradicated at the end of all therapy. There were no unexpected adverse events with the use of IV ciprofloxacin. The overall incidence of adverse events was 11%, wit h 21 (81%) of 26 events judged to be mild or moderate, and only 5 (19% ) of 26 as severe. Treatment had to be discontinued because of adverse events in only 8 (5.4%) of 149 patients. When appropriately prescribe d, parenteral ciprofloxacin followed by oral ciprofloxacin is an effec tive, safe, and potentially cost-saving antimicrobial regimen, with no loss of clinical or bacteriologic efficacy associated with this switc h to the oral formulation.