TY - JOUR
T1 - Comparison of tigecycline with imipenem/cilastatin for the treatment of hospital-acquired pneumonia
AU - Freire, Antonio T.
AU - Melnyk, Vasyl
AU - Min, Ja Kim
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
PY - 2010/10/1
Y1 - 2010/10/1
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
UR - http://www.scopus.com/inward/record.url?scp=77956576770&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77956576770&partnerID=8YFLogxK
U2 - 10.1016/j.diagmicrobio.2010.05.012
DO - 10.1016/j.diagmicrobio.2010.05.012
M3 - Article
C2 - 20846586
AN - SCOPUS:77956576770
VL - 68
SP - 140
EP - 151
JO - Diagnostic Microbiology and Infectious Disease
JF - Diagnostic Microbiology and Infectious Disease
SN - 0732-8893
IS - 2
ER -