title: 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.
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.
authors.affiliation: Theravance Biopharma US, Inc., South San Francisco, California, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Pushkin
authors.affiliation: Theravance Biopharma US, Inc., South San Francisco, California, USA.
authors.forename: Steven L
authors.initials: SL
authors.lastname: Barriere
authors.affiliation: Theravance Biopharma US, Inc., South San Francisco, California, USA WWang@theravance.com.
authors.forename: Whedy
authors.initials: W
authors.lastname: Wang
authors.affiliation: Duke Clinical Research Institute and Division of Infectious Diseases, Duke University Medical Center, Durham, North Carolina, USA.
authors.forename: G Ralph
authors.initials: GR
authors.lastname: Corey
authors.affiliation: Department of Medicine, Section of Infectious Diseases, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno (CEMIC), Buenos Aires, Argentina.
authors.forename: Martin E
authors.initials: ME
authors.lastname: Stryjewski
mesh_terms: D000328:Adult; D000368:Aged; D000617:Aminoglycosides / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D006801:Humans; D000077427:Lipoglycopeptides; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012874:Skin Diseases, Infectious / Q000188:drug therapy*; D014640:Vancomycin / Q000627:therapeutic use
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000077427:Lipoglycopeptides; D014640:Vancomycin; C487637:telavancin