A multi-centre, phase IV study to evaluate the steady-state plasma concentration and serum bactericidal activity of a generic teicoplanin preparation

Abstract

Introduction: Teicoplanin is an effective treatment option against methicillin-resistant, Gram-positive bacteria, like Staphylococcus aureus. It is a glycopeptide antibiotic, produced through microbial fermentation, a process resulting in variations in the N-acyl side chain. Concerns that these variations may affect the pharmacokinetic profile and the clinical efficacy of generic teicoplanin preparations have been raised.Method: To address this issue, a multi-centre observational study was conducted to evaluate steady-state peak and trough serum concentrations, and the serum bactericidal activity (SBA) and safety of a generic teicoplanin preparation in critically ill patients. Additionally, the composition of the generic teicoplanin was compared to that of the innovator drug to assess differences in the composition.Results: Following pre-determined loading and maintenance dose schedules, the mean peak and trough teicoplanin serum concentrations were 20.98 mg/l and 10.38 mg/l, respectively. A statistically...