Efficacy and safety of doripenem versus piperacillin/tazobactam in nosocomial pneumonia: a randomized, open-label, multicenter study

ABSTRACT Objective: Doripenem is a new carbapenem that has broad-spectrum activity against bacterial pathogens commonly responsible for nosocomial pneumonia (NP). It has several advantages over currently available carbapenems and other classes of drugs used in this indication. This prospective, rand...

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Bibliographic Details
Published in:Current medical research and opinion 2008-07, Vol.24 (7), p.2113-2126
Main Authors: Réa-Neto, Álvaro, Niederman, Michael, Margareth Lobo, Suzana, Schroeder, Eric, Lee, Michael, Kaniga, Koné, Ketter, Nzeera, Prokocimer, Philippe, Friedland, Ian
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Anti-Bacterial Agents - therapeutic use
Bacteria - drug effects
Bacteria - isolation & purification
Carbapenem
Carbapenems - therapeutic use
Cross Infection - drug therapy
Cross Infection - microbiology
Doripenem
Female
Humans
Klebsiella pneumoniae
Male
Middle Aged
Penicillanic Acid - analogs & derivatives
Penicillanic Acid - therapeutic use
Piperacillin - therapeutic use
Pneumonia, Bacterial - drug therapy
Prospective Studies
Pseudomonas aeruginosa
Tazobactam
Treatment Outcome
Ventilator-associated pneumonia
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Summary:ABSTRACT Objective: Doripenem is a new carbapenem that has broad-spectrum activity against bacterial pathogens commonly responsible for nosocomial pneumonia (NP). It has several advantages over currently available carbapenems and other classes of drugs used in this indication. This prospective, randomized, open-label, multicenter study was designed to establish whether doripenem was noninferior to piperacillin/tazobactam in NP. Methods: Adults (n = 448) with signs and symptoms of NP, including non-ventilated patients and those ventilated for 8 µg/mL occurred in 0% and 7.7%, respectively. Favorable microbiological outcome rates against Gram-negative pathogens were numerically higher with doripenem than with piperacillin/tazobactam, but the difference was not statistically significant. Both study drugs were generally well tolerated, as only 16.1% and 17.6% of patients receiving doripenem and piperacillin/tazobactam, respectively, had a drug-related adverse event. Study limitations included the open-label design, the low rate of monotherapy (adjunctive use of aminoglycoside was required when P. aeruginosa was suspected), and the exclusion of the m
ISSN:0300-7995
1473-4877
DOI:10.1185/03007990802179255