Oral trovafloxacin compared with intravenous cefoxitin in the prevention of bacterial infection after elective vaginal or abdominal hysterectomy for nonmalignant disease

BACKGROUND: Trovafloxacin is a new fourth-generation fluoroquinolone whose pharmacokinetics and in vitro activity suggest that it is well suited for a ntibiotic prophylaxis in elective hysterectomy. METHODS: In a randomized, double-blind, multicenter study, parallel groups of women 18 years of age or older received either 200 mg trovafloxacin by m outh and intravenous (IV) placebo or 2 g cefoxitin by IV infusion and place bo by mouth before elective vaginal or abdominal hysterectomy for nonmalign ant disease. RESULTS: In the 103 and 97 patients in the trovafloxacin and cefoxitin grou ps, respectively, who were evaluable for efficacy, the prophylactic success rates at hospital discharge (96% in both groups) and 30 +/- 6 days after h ysterectomy (88% and 91% in the trovafloxacin and cefoxitin groups, respect ively) were statistically equivalent; Both antibiotics were well tolerated. CONCLUSION: A Single oral 200 mg dose of trovafloxacin is as effective and safe as a standard cefoxitin parenteral regimen in the prevention of primar y bacterial infection after elective vaginal or abdominal hysterectomy for nonmalignant disease. (C) 1998 by Excerpta Medica, Inc.