Treatment of acute gynecologic infections with trovafloxacin

BACKGROUND: Trovafloxacin, a broad-spectrum fourth-generation quinolone wit h gram-positive and gram-negative aerobic and anaerobic bacterial activity, is available in oral and intravenous formulations. The objective of this p rospective, multicenter, double-blind, randomized study was to compare the efficacy of trovafloxacin with that of cefoxitin, an approved drug for trea tment of acute gynecologic infections, together with amoxicillin/clavulanic acid as oral follow-on treatment. METHODS: Patients with a clinical diagnosis of acute pelvic infection recei ved either intravenous alatrofloxacin with oral trovafloxacin follow-on (tr ovafloxacin) or a combined regimen of cefoxitin followed by amoxicillin/cla vulanic acid for a maximum of 14 days. The primary endpoint was clinical re sponse to therapy on follow-up at day 30. RESULTS: Clinical success rates were comparable between the trovafloxacin ( n = 107) and comparative (n = 119) groups at study end (90% vs. 86%, respec tively; 95% confidence interval, -4.5, 12.5). Among clinically evaluable pa tients, clinical success rates for infections involving Enterococcus specie s were higher with trovafloxacin than with the comparative regimen at the e nd of treatment (96% and 85%) and at study end (96% and 86%). CONCLUSION: Intravenous alatrofloxacin followed by oral trovafloxacin for a maximum of 14 days of total therapy was efficacious in the treatment of ac ute pelvic infections. (C) 1998 by Excerpta Medica, Inc.