Key result
Telavancin had a minimal effect on cardiac repolarization, with placebo-corrected mean changes in QTcF of 4.1 msec and 4.5 msec for 7.5 mg/kg and 15 mg/kg doses, respectively.
Why the study?
Does telavancin prolong the QTc interval compared to placebo in healthy subjects?
Population
160 healthy subjects
Comparison
Telavancin 7.5 mg/kg or 15 mg/kg once daily for… vs Placebo or moxifloxacin 400 mg once daily for 3…
Design
RCT, randomized into four groups, ECGs analyzed digitally in a blinded fashion
Follow-up
3 days
Authors
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Supports telavancin use without routine QT monitoring; confirms minimal repolarization effect across doses in this RCT.
RCT (n=160)
Blinded
randomized
Does telavancin prolong the QTc interval compared to placebo in healthy subjects?
Mean Difference: 4.5
Telavancin has a minimal (<5 msec) effect on cardiac repolarization with a flat dose-response over a two-fold exposure range.
Barriere et al. (2004) conducted an RCT in Healthy subjects (n=160). Telavancin vs. Placebo and moxifloxacin 400 mg was evaluated on QT data corrected for heart rate by the Fridericia formula (QTcF) (Placebo-corrected mean change 4.1 msec and 4.5 msec). Telavancin had a minimal effect on cardiac repolarization, with placebo-corrected mean changes in QTcF of 4.1 msec and 4.5 msec for 7.5 mg/kg and 15 mg/kg doses, respectively.
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