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Oritavancin, a New Lipoglycopeptide Antibiotic: Results From a Thorough QT Study

Oritavancin is a lipoglycopeptide with broad activity against gram‐positive bacteria. To exclude an effect on cardiac repolarization, oritavancin was studied in a thorough QT study. In vitro assays have demonstrated a 10‐fold safety margin between the concentration that resulted in 50% block of the cardiac potassium current and therapeutic plasma levels in patients and no safety margin for block of the sodium currents. In a parallel‐group study, 240 male and female subjects received treatment with either the clinical dose (200 mg intravenously) or a supratherapeutic dose (800 mg intravenously) of oritavancin, placebo, or a positive control (400 mg of oral moxifloxacin). Electrocardiograms were recorded in triplicate at several time points after dosing. The primary end point was the largest baseline‐adjusted, placebo‐corrected QTcI observed at any point after oritavancin dosing. The study's sensitivity to demonstrate a sufficiently small QTc change was confirmed by the moxifloxacin effect. The baseline‐adjusted, placebo‐corrected QTcl was between −3 milliseconds and 3 milliseconds after 800 mg of oritavancin, and an effect exceeding 6 milliseconds was confidently excluded. Other electrocardiographic parameters were unaffected by the treatment. It was concluded that oritavancin did not cause QTc prolongation in this thorough QT study.