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

Autor: Min Ja Kim, Felix Glumcher, Hassan Gandjini, Antonio T. Freire, C. Angel Cooper, Nathalie Dartois, Oleksiy Datsenko, Yin Ching Chuang, Vasyl Melnyk, Oleksandr Dzyublik, Gary Dukart, Robert Maroko, Joan M. Korth-Bradley
Rok vydání: 2009
Předmět:
Zdroj: Diagnostic microbiology and infectious disease. 68(2)
ISSN: 1879-0070
Popis: 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.
Databáze: OpenAIRE