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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.

Publication ,  Journal Article
Pushkin, R; Barriere, SL; Wang, W; Corey, GR; Stryjewski, ME
Published in: Antimicrob Agents Chemother
October 2015

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.

Duke Scholars

Published In

Antimicrob Agents Chemother

DOI

EISSN

1098-6596

Publication Date

October 2015

Volume

59

Issue

10

Start / End Page

6170 / 6174

Location

United States

Related Subject Headings

  • Vancomycin
  • Skin Diseases, Infectious
  • Retrospective Studies
  • Randomized Controlled Trials as Topic
  • Middle Aged
  • Microbiology
  • Male
  • Lipoglycopeptides
  • Humans
  • Female
 

Citation

APA
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Pushkin, R., Barriere, S. L., Wang, W., Corey, G. R., & Stryjewski, M. E. (2015). 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. Antimicrob Agents Chemother, 59(10), 6170–6174. https://doi.org/10.1128/AAC.00471-15
Pushkin, Richard, Steven L. Barriere, Whedy Wang, G Ralph Corey, and Martin E. Stryjewski. “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.Antimicrob Agents Chemother 59, no. 10 (October 2015): 6170–74. https://doi.org/10.1128/AAC.00471-15.
Pushkin R, Barriere SL, Wang W, Corey GR, Stryjewski ME. 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. Antimicrob Agents Chemother. 2015 Oct;59(10):6170–4.
Pushkin, Richard, et al. “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.Antimicrob Agents Chemother, vol. 59, no. 10, Oct. 2015, pp. 6170–74. Pubmed, doi:10.1128/AAC.00471-15.
Pushkin R, Barriere SL, Wang W, Corey GR, Stryjewski ME. 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. Antimicrob Agents Chemother. 2015 Oct;59(10):6170–6174.

Published In

Antimicrob Agents Chemother

DOI

EISSN

1098-6596

Publication Date

October 2015

Volume

59

Issue

10

Start / End Page

6170 / 6174

Location

United States

Related Subject Headings

  • Vancomycin
  • Skin Diseases, Infectious
  • Retrospective Studies
  • Randomized Controlled Trials as Topic
  • Middle Aged
  • Microbiology
  • Male
  • Lipoglycopeptides
  • Humans
  • Female