Double-blind, multicenter, prospective randomized study of trospectomycin vs. Clindamycin, both with aztreonam, in non-community acquired obstetric and gynecologic infections

Abstract

Objective: The purpose of this study was to compare the clinical efficacy and safety of trospectomycin sulfate with that of clindamycin phosphate, both with aztreonam, for the treatment of obstetric and gynecologic infections.

Methods: In a double-blind, multicenter, prospective randomized study, 579 patients with either endometritis following cesarean delivery or pelvic cellulitis following hysterectomy were enrolled and received medication. Administered was either trospectomycin sulfate 500 mg IV every 8 h or clindamycin phosphate 900 mg IV every 8 h in a 1:1 randomization ratio. Both groups of patients received aztreonam 1 g IV every 8 h. The patients were followed for clinical responses and side effects.

Results: The cure rate for the trospectomycin sulfate arm was 91.8% and for clindamycin phosphate arm it was 88.4% (P = 0.218). The adverse events were similar in both groups.

Conclusions: Trospectomycin was as effective as clindamycin, when both were combined with aztreonam, in treatment of obstetric and gynecologic infections.