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

doi:10.1016/j.diagmicrobio.2010.05.012

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

Department of Biomedical Sciences

Research output: Contribution to journal › Article › peer-review

237 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 language	English
Pages (from-to)	140-151
Number of pages	12
Journal	Diagnostic Microbiology and Infectious Disease
Volume	68
Issue number	2
DOIs	https://doi.org/10.1016/j.diagmicrobio.2010.05.012
Publication status	Published - 2010 Oct

Keywords

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

ASJC Scopus subject areas

Microbiology (medical)
Infectious Diseases

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.diagmicrobio.2010.05.012

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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

Freire, AT, Melnyk, V, Kim, MJ, Datsenko, O, Dzyublik, O, Glumcher, F, Chuang, YC, Maroko, RT, Dukart, G, Cooper, CA, Korth-Bradley, JM, Dartois, N & Gandjini, H 2010, 'Comparison of tigecycline with imipenem/cilastatin for the treatment of hospital-acquired pneumonia', Diagnostic Microbiology and Infectious Disease, vol. 68, no. 2, pp. 140-151. https://doi.org/10.1016/j.diagmicrobio.2010.05.012

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title = "Comparison of tigecycline with imipenem/cilastatin for the treatment of hospital-acquired pneumonia",

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.",

keywords = "Antimicrobial, Glycylcycline, Nosocomial, Pneumonia, Ventilator/non-ventilator-associated pneumonia",

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

note = "Funding Information: Finanziamenti: questo lavoro {\`e} stato finanziato dal Medical Research Council come parte del MRCeNational Institute for Health Research (NIHR) Methodology Research Programme (Grant number MR/ K01465X/1). Il tempo di B.C.R. per contribuire allo studio {\`e} stato fi-nanziato dal NIHR Bristol Biomedical Research Unit in Cardiovascular Disease. D.M.C. {\`e} supportato dal Medical Research Council (UK) Population Health Science fellowship (G0902118).",

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doi = "10.1016/j.diagmicrobio.2010.05.012",

language = "English",

volume = "68",

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T1 - Comparison of tigecycline with imipenem/cilastatin for the treatment of hospital-acquired pneumonia

AU - Freire, Antonio T.

AU - Melnyk, Vasyl

AU - Kim, Min Ja

AU - Datsenko, Oleksiy

AU - Dzyublik, Oleksandr

AU - Glumcher, Felix

AU - Chuang, Yin Ching

AU - Maroko, Robert T.

AU - Dukart, Gary

AU - Cooper, C. Angel

AU - Korth-Bradley, Joan M.

AU - Dartois, Nathalie

AU - Gandjini, Hassan

N1 - Funding Information: Finanziamenti: questo lavoro è stato finanziato dal Medical Research Council come parte del MRCeNational Institute for Health Research (NIHR) Methodology Research Programme (Grant number MR/ K01465X/1). Il tempo di B.C.R. per contribuire allo studio è stato fi-nanziato dal NIHR Bristol Biomedical Research Unit in Cardiovascular Disease. D.M.C. è supportato dal Medical Research Council (UK) Population Health Science fellowship (G0902118).

PY - 2010/10

Y1 - 2010/10

N2 - 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.

AB - 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.

KW - Antimicrobial

KW - Glycylcycline

KW - Nosocomial

KW - Pneumonia

KW - Ventilator/non-ventilator-associated pneumonia

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

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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