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2015 ; 59
(10
): 6170-4
Nephropedia Template TP
gab.com Text
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English Wikipedia
Telavancin for Acute Bacterial Skin and Skin Structure Infections, a Post Hoc
Analysis of the Phase 3 ATLAS Trials in Light of the 2013 FDA Guidance
#MMPMID26248356
Pushkin R
; Barriere SL
; Wang W
; Corey GR
; Stryjewski ME
Antimicrob Agents Chemother
2015[Oct]; 59
(10
): 6170-4
PMID26248356
show ga
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 sizes of ?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 a ?20%
reduction in lesion size from baseline and no rescue antibiotic. Updated
test-of-cure (TOC) clinical response was defined as a ?90% reduction in lesion
size, no increase in lesion size since day 3, and no requirement for additional
antibiotics or significant surgical procedures. Day 3 (early) clinical responses
were achieved in 62.6% and 61.0% of patients receiving telavancin and vancomycin,
respectively (difference, 1.7%, with a 95% confidence interval [CI] of -4.0% to
7.4%). Updated TOC visit cure rates were similar for telavancin (68.0%) and
vancomycin (63.3%), with a difference of 4.8% (95% CI, -0.7% to 10.3%). Adopting
current FDA guidance, this analysis corroborates previous noninferiority findings
of the ATLAS trials of telavancin compared with vancomycin.