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Telavancin for hospital-acquired pneumonia: clinical response and 28-day survival.

Publication ,  Journal Article
Corey, GR; Kollef, MH; Shorr, AF; Rubinstein, E; Stryjewski, ME; Hopkins, A; Barriere, SL
Published in: Antimicrob Agents Chemother
2014

U.S. Food and Drug Administration draft guidance for future antibiotic clinical trials of bacterial nosocomial pneumonia recommends the use of diagnostic criteria according to American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) guidelines and the use of a primary endpoint of 28-day all-cause mortality. The effect of applying these guidelines on outcomes of phase III nosocomial pneumonia studies of telavancin was evaluated in a post hoc analysis. ATS/IDSA criteria were applied in a blind fashion to the original all-treated (AT) group. Clinical cure rates at final follow-up were determined in the refined AT and clinically evaluable (CE) groups (ATS/IDSA-AT and ATS/IDSA-CE, respectively). The exploratory endpoint of 28-day survival was evaluated for the ATS/IDSA-AT group. Noninferiority of telavancin versus vancomycin was demonstrated, with similar cure rates in the ATS/IDSA-AT (59% versus 59%) and ATS/IDSA-CE (83% versus 80%) groups. Cure rates favored telavancin in ATS/IDSA-CE patients where Staphylococcus aureus was the sole pathogen (86% versus 75%). Overall, 28-day survival rates were similar in the telavancin (76%) and vancomycin (77%) groups but lower in telavancin-treated patients with preexisting moderate-to-severe renal impairment (creatinine clearance [CLCR] of <50 ml/min). Telavancin should be administered to patients with moderate-to-severe renal impairment only if treatment benefit outweighs the risk or if no suitable alternatives are available.

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Published In

Antimicrob Agents Chemother

DOI

EISSN

1098-6596

Publication Date

2014

Volume

58

Issue

4

Start / End Page

2030 / 2037

Location

United States

Related Subject Headings

  • Vancomycin
  • United States
  • Staphylococcus aureus
  • Pneumonia
  • Middle Aged
  • Microbiology
  • Male
  • Lipoglycopeptides
  • Humans
  • Female
 

Citation

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Corey, G. R., Kollef, M. H., Shorr, A. F., Rubinstein, E., Stryjewski, M. E., Hopkins, A., & Barriere, S. L. (2014). Telavancin for hospital-acquired pneumonia: clinical response and 28-day survival. Antimicrob Agents Chemother, 58(4), 2030–2037. https://doi.org/10.1128/AAC.02330-13
Corey, G Ralph, Marin H. Kollef, Andrew F. Shorr, Ethan Rubinstein, Martin E. Stryjewski, Alan Hopkins, and Steven L. Barriere. “Telavancin for hospital-acquired pneumonia: clinical response and 28-day survival.Antimicrob Agents Chemother 58, no. 4 (2014): 2030–37. https://doi.org/10.1128/AAC.02330-13.
Corey GR, Kollef MH, Shorr AF, Rubinstein E, Stryjewski ME, Hopkins A, et al. Telavancin for hospital-acquired pneumonia: clinical response and 28-day survival. Antimicrob Agents Chemother. 2014;58(4):2030–7.
Corey, G. Ralph, et al. “Telavancin for hospital-acquired pneumonia: clinical response and 28-day survival.Antimicrob Agents Chemother, vol. 58, no. 4, 2014, pp. 2030–37. Pubmed, doi:10.1128/AAC.02330-13.
Corey GR, Kollef MH, Shorr AF, Rubinstein E, Stryjewski ME, Hopkins A, Barriere SL. Telavancin for hospital-acquired pneumonia: clinical response and 28-day survival. Antimicrob Agents Chemother. 2014;58(4):2030–2037.

Published In

Antimicrob Agents Chemother

DOI

EISSN

1098-6596

Publication Date

2014

Volume

58

Issue

4

Start / End Page

2030 / 2037

Location

United States

Related Subject Headings

  • Vancomycin
  • United States
  • Staphylococcus aureus
  • Pneumonia
  • Middle Aged
  • Microbiology
  • Male
  • Lipoglycopeptides
  • Humans
  • Female