Meropenem versus imipenem-cilastatin for the treatment of hospitalized patients with complicated skin and skin structure infections: Results of multicenter, randomized, double-blind comparative study

Timothy C. Fabian, Thomas M. File, John M. Embil, Jacobus E.J. Krige, Stanley Klein, Andrea Rose, David Melnick, Norberto E. Soto, Mujahed Abbas, David Adler, Alfred Bacon, Daniel Barbaro, Lonson Barr, Professor Becker, Jean Francois Bellemare, Kevin Berkowitz, Steven Berman, Leon Brill, Larry Bush, Ellis CaplanShanana Choudhury, Nicolas Christou, Mark Davies, Thomas DeMarini, Y. Desai, Thomas Dickey, Maciej Dryjski, Lawrence Eron, Vincent Falanga, Lewis Flint, William Flynn, Marcelo Gareca, John Gezon, Fernando Ghimenton, Marc H. Glickman, Faldir Golin, Donald Graham, R. Moss Hampton, Godfrey Harding, Stuart Harin, Mark Harrison, Hoi Ho, Wendall Hoffman, John Hunt, Lourdes Irizarry, Luis Jauregui, Walid Khayr, Robert Kingman, Donald Levine, Michael Libman, Carlos Lotfi, Christopher Lucasti, Arnold Luterman, John Mazuski, Robert McIntyre, Michael McMillian, James H. Mersey, Miller A. Miller, Preston Miller, Gregory Moran, Ann Mushinsky-Tralles, James Murray, Michael Natalino, Preeti Nautiyal, Frances Pien, Rhonda Quick, Ramon Ramirez, Karlene Reid, William Reiter, Charles Richardt, Selwyn Rogers, Jane Rohlf, Steven Royall, Christian Schrock, Robert Schwartz, Marc J. Sharpiro, Priscilla Sioson, Lewis Brain Somberg, Judy Stone, Carlos Straling, William Tapscott, Fabian Tun, William Turner, Louis van Zyl, Leonard Weireter, Samuel Eric Wilson, Neilson Wright, Kim Young, Marcus Zervos, Stephen Zellner

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32 Scopus citations

Abstract

Background: Meropenem, a broad-spectrum carbapenem with potent in vitro activity, is postulated to be an effective monotherapy for the treatment of complicated skin and skin structure infections (cSSSI). Methods: This multicenter, international, double-blind, randomized, prospective study of hospitalized patients with cSSSI evaluated the efficacy, safety, and tolerability of meropenem (500 mg IV q8h) versus imipenem-cilastatin (500 mg IV q8h). The primary efficacy endpoint was clinical outcome at follow-up in the clinically evaluable (CE) and modified intent-to-treat populations (MITT; patients who met eligibility criteria and received at least one dose of study drug). The study aimed to demonstrate non-inferiority (delta of 10%, 95% confidence intervals) in clinical response in the CE population. Clinical responses for all pathogens at follow-up were assessed in the fully evaluable population (CE population with baseline pathogen and follow-up cultures). Results: In total, 1,076 patients were enrolled. Of these, 692 patients comprised the MITT population (334 and 358 patients randomized to meropenem and imipenem-cilastatin, respectively) and 548 the CE population (261 and 287 patients randomized to meropenem and imipenem-cilastatin, respectively). Cure rates were 86.2% (meropenem) and 82.9% (imipenemcilastatin; 95% CI, -2.8, 9.3) in the CE population and 73.1% (meropenem) and 74.9% (imipenem-cilastatin; 95% CI, -8.4, 4.7) in the MITT population. The frequencies of adverse events and drug-related adverse events were similar between treatment groups. Conclusion: In one of the largest studies conducted to date of hospitalized patients with cSSSI, meropenem, 500 mg IV q8h had comparable safety and efficacy to imipenem-cilastatin, 500 mg IV q8h.

Original languageEnglish
Pages (from-to)269-282
Number of pages14
JournalSurgical infections
Volume6
Issue number3
DOIs
StatePublished - Sep 1 2005
Externally publishedYes

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    Fabian, T. C., File, T. M., Embil, J. M., Krige, J. E. J., Klein, S., Rose, A., Melnick, D., Soto, N. E., Abbas, M., Adler, D., Bacon, A., Barbaro, D., Barr, L., Becker, P., Bellemare, J. F., Berkowitz, K., Berman, S., Brill, L., Bush, L., ... Zellner, S. (2005). Meropenem versus imipenem-cilastatin for the treatment of hospitalized patients with complicated skin and skin structure infections: Results of multicenter, randomized, double-blind comparative study. Surgical infections, 6(3), 269-282. https://doi.org/10.1089/sur.2005.6.269