Comparison of tigecycline with imipenem/cilastatin for the treatment of hospital-acquired pneumonia

Antonio T. Freire, Vasyl Melnyk, Min Ja Kim, Oleksiy Datsenko, Oleksandr Dzyublik, Felix Glumcher, Yin Ching Chuang, Robert T. Maroko, Gary Dukart, C. Angel Cooper, Joan M. Korth-Bradley, Nathalie Dartois, Hassan Gandjini

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199 Citations (Scopus)

Abstract

To compare efficacy and safety of a tigecycline regimen with an imipenem/cilastatin regimen in hospital-acquired pneumonia patients, a phase 3, multicenter, randomized, double-blind, study evaluated 945 patients. Coprimary end points were clinical response in clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) populations at test-of-cure. Cure rates were 67.9% for tigecycline and 78.2% for imipenem (CE patients) and 62.7% and 67.6% (c-mITT patients), respectively. A statistical interaction occurred between ventilator-associated pneumonia (VAP) and non-VAP subgroups, with significantly lower cure rates in tigecycline VAP patients compared to imipenem; in non-VAP patients, tigecycline was noninferior to imipenem. Overall mortality did not differ between the tigecycline (14.1%) and imipenem regimens (12.2%), although more deaths occurred in VAP patients treated with tigecycline than imipenem. Overall, the tigecycline regimen was noninferior to the imipenem/cilastatin regimen for the c-mITT but not the CE population; this difference appears to have been driven by results in VAP patients.

Original languageEnglish
Pages (from-to)140-151
Number of pages12
JournalDiagnostic Microbiology and Infectious Disease
Volume68
Issue number2
DOIs
Publication statusPublished - 2010 Oct

Keywords

  • Antimicrobial
  • Glycylcycline
  • Nosocomial
  • Pneumonia
  • Ventilator/non-ventilator-associated pneumonia

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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  • Cite this

    Freire, A. T., Melnyk, V., Kim, M. J., Datsenko, O., Dzyublik, O., Glumcher, F., Chuang, Y. C., Maroko, R. T., Dukart, G., Cooper, C. A., Korth-Bradley, J. M., Dartois, N., & Gandjini, H. (2010). Comparison of tigecycline with imipenem/cilastatin for the treatment of hospital-acquired pneumonia. Diagnostic Microbiology and Infectious Disease, 68(2), 140-151. https://doi.org/10.1016/j.diagmicrobio.2010.05.012