Double-blind comparison of single-dose alatrofloxacin and cefotetan as prophylaxis of infection following elective colorectal surgery

BACKGROUND: Alatrofloxacin, the prodrug of trovafloxacin, is a novel fluoro quinolone antimicrobial agent with a broad spectrum, including activity aga inst: gram-positive and gram-negative aerobes and anaerobes, Its pharmacoki netic properties (long half-life, excellent tissue distribution, and good s afety profile) suggest a role in surgical prophylaxis. This prospective, mu lticenter, double-blind trial compared alatrofloxacin with cefotetan, an ap proved drug for surgical prophylaxis, in reducing postoperative infections. METHODS: The efficacy and safety of a single 200-mg intravenous dose of ala trofloxacin were compared to a single 2-g intravenous dose of cefotetan in 492 patients undergoing elective colorectal surgery. The efficacy of alatro floxacin as a prophylaxis for wound, intra-abdominal, or remote-site postop erative infectious complications was compared with cefotetan in 317 clinica lly evaluable patients; 161 received alatrofloxacin and 156 received cefote tan. The patients were monitored for infections and safety for 30 days post operatively. RESULTS: NO statistically significant between-treatment difference was dete cted in successful clinical response rates at the end of the study (72% for each group). The incidence of primary wound infections at the time of hosp ital discharge was also similar: 21% in patients treated with alatrofloxaci n and 18% in those treated with cefotetan. Safety, established by the incid ence of adverse events, did not differ statistically between the groups. CONCLUSIONS: A single intravenous dose of alatrofloxacin given within 4 hou rs prior to surgery was as effective as an intravenous dose of cefotetan in the prevention of postoperative infectious complications in patients under going elective colorectal surgery. The safety profiles of the two medicatio ns were similar. (C) 1998 by Excerpta Medica, Inc.