Journal Article

Safety of Intravenous Infusion of Doripenem

Rebecca Redman and Thomas M. File

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 49, issue Supplement_1, pages S28-S29
Published in print August 2009 | ISSN: 1058-4838
Published online August 2009 | e-ISSN: 1537-6591 | DOI: https://dx.doi.org/10.1086/599813
Safety of Intravenous Infusion of Doripenem

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Carbapenems remain a mainstay for the empirical treatment of serious nosocomial infection. Although the tolerance and safety profile of the carbapenems as a class is favorable, the primary safety concern is the potential for treatment-emergent seizures. In preclinical testing, doripenem, a new carbapenem antibiotic, showed negligible neurotoxic effects. The safety and tolerability of intravenous doripenem was evaluated in 1 phase 2 and in 6 phase 3 clinical trials conducted with patients with nosocomial pneumonia, including ventilator-associated pneumonia; complicated intra-abdominal infection; and complicated urinary tract infection. Safety data were available from 1817 patients who received doripenem and 1325 patients who received 1 of 4 active comparator drugs as part of this development program. Overall, intravenous doripenem was found to be safe and well tolerated, demonstrating a safety profile comparable to that of comparator agents and a limited propensity to induce seizures, including when administered via 1-h or 4-h infusion.

Journal Article.  5411 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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