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Telavancin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) - A Post-hoc Analysis of the Phase 3 ATLAS Trials in Consideration of the Final (2013) FDA Guidance.
Antimicrob Agents Chemother. 2015 Jul 27;
Authors: Pushkin R, Barriere SL, Wang W, Corey GR, Stryjewski ME
Abstract
Two phase 3 ATLAS trials demonstrated noninferiority of telavancin compared with vancomycin for complicated skin and skin structure infections. Data from these trials were retrospectively evaluated according to 2013 U.S. Food and Drug Administration (FDA) guidance on acute bacterial skin and skin structure infections. This post hoc analysis included patients with lesion size ≥75 cm(2) and excluded patients with ulcers or burns (updated all-treated population, N = 1,127). Updated Day 3/early clinical response was defined as ≥20% reduction in lesion size from baseline and no rescue antibiotic. Updated test-of-cure (TOC) clinical response was defined as ≥90% reduction in lesion size, no increase in lesion size since Day 3, and no requirement for additional antibiotics/significant surgical procedures. Day 3/early clinical responses were achieved in 62.6% and 61.0% of patients receiving telavancin and vancomycin, respectively (difference [95% confidence interval (CI)]: 1.7% [-4.0% to 7.4%]). Updated TOC cure rates were similar for telavancin (68.0%) and vancomycin (63.3%); difference (95% CI): 4.8% (-0.7% to 10.3%). Adopting current FDA guidance, this analysis corroborates previous noninferiority findings of the ATLAS trials of telavancin compared with vancomycin.
PMID: 26248356 [PubMed - as supplied by publisher]