Prospective, double-blind, randomized trial of teicoplanin versus vancomycin for the therapy of vascular access-associated bacteremia caused by gram-positive pathogens

A total of 240 patients with suspected bacteremia/septicemia secondary to vascular access-associated gram-positive infection was enrolled in a multicenter trial in 47 centers in the United States and Canada, comparing teicoplanin (3 x 6 mg/kg 12-hourly, then 6 mg/kg 24-hourly) with vancomycin (15 mg/kg 12-hourly). Groups were well matched for all demographic variables. In all, 124 patients were evaluable for efficacy in the 'per protocol' analysis (60 receiving teicoplanin and 64 receiving vancomycin). Clinical cure and improvement was achieved in 48 (80.0%) of 60 patients for teicoplanin and 51 (79.7%) of 64 patients for vancomycin. 'Intent-to-treat' analysis also showed similar efficacy for the two glycopeptides. The pathogens most often isolated were coagulase-negative staphylococci (64 patients) and Staphylococcus aureus (60 patients). Eradication was achieved in 49 (81.7%) of 60 patients for teicoplanin and 55 (85.9%) of 64 patients for vancomycin. Serum level data were available for 170 episodes. Adverse events were reported by 32 (27.4%) of 117 patients receiving teicoplanin and 37 (30.6%) of 121 patients receiving vancomycin. The most often reported adverse events, other than gastrointestinal events, were hypersensitivity reactions (rash, pruritus, and fever). There were no differences between the groups for the types of events experienced. In all, 15 of 240 patients included in the safety analysis (7/118 [5.9%] receiving teicoplanin and 8/122 [6.6%] receiving vancomycin) discontinued treatment due to adverse events. It is concluded that teicoplanin and vancomycin show equivalent efficacy and tolerance in vascular access-associated bacteremia/septicemia caused by gram- positive pathogens.