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.

July 15, 2016 at 9:10 am

Antimicrob Agents Chemother. 2015 Oct;59(10):6170-4.

Pushkin R1, Barriere SL1, Wang W2, Corey GR3, Stryjewski ME4.

Author information

1Theravance Biopharma US, Inc., South San Francisco, California, USA.

2Theravance Biopharma US, Inc., South San Francisco, California, USA WWang@theravance.com.

3Duke Clinical Research Institute and Division of Infectious Diseases, Duke University Medical Center, Durham, North Carolina, USA.

4Department of Medicine, Section of Infectious Diseases, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno (CEMIC), Buenos Aires, Argentina.

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 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.

PDF

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4576104/pdf/zac6170.pdf

Entry filed under: Antimicrobianos, Bacterias, Bacteriemias, Infecciones en piel y tej blandos, Metodos diagnosticos, Resistencia bacteriana, Sepsis, Update. Tags: .

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