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 Caplan & 70 others Shanana 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

Research output: Contribution to journalArticle

32 Citations (Scopus)

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 (US)
Pages (from-to)269-282
Number of pages14
JournalSurgical Infections
Volume6
Issue number3
DOIs
StatePublished - Sep 2005
Externally publishedYes

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meropenem
Double-Blind Method
Skin
Infection
Population
Therapeutics
Safety
Carbapenems
imipenem drug combination cilastatin
Drug-Related Side Effects and Adverse Reactions

ASJC Scopus subject areas

  • Surgery
  • Microbiology (medical)
  • Infectious Diseases

Cite this

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

In: Surgical Infections, Vol. 6, No. 3, 09.2005, p. 269-282.

Research output: Contribution to journalArticle

Fabian, TC, File, TM, Embil, JM, Krige, JEJ, Klein, S, Rose, A, Melnick, D, Soto, NE, Abbas, M, Adler, D, Bacon, A, Barbaro, D, Barr, L, Becker, P, Bellemare, JF, Berkowitz, K, Berman, S, Brill, L, Bush, L, Caplan, E, Choudhury, S, Christou, N, Davies, M, DeMarini, T, Desai, Y, Dickey, T, Dryjski, M, Eron, L, Falanga, V, Flint, L, Flynn, W, Gareca, M, Gezon, J, Ghimenton, F, Glickman, MH, Golin, F, Graham, D, Hampton, RM, Harding, G, Harin, S, Harrison, M, Ho, H, Hoffman, W, Hunt, J, Irizarry, L, Jauregui, L, Khayr, W, Kingman, R, Levine, D, Libman, M, Lotfi, C, Lucasti, C, Luterman, A, Mazuski, J, McIntyre, R, McMillian, M, Mersey, JH, Miller, MA, Miller, P, Moran, G, Mushinsky-Tralles, A, Murray, J, Natalino, M, Nautiyal, P, Pien, F, Quick, R, Ramirez, R, Reid, K, Reiter, W, Richardt, C, Rogers, S, Rohlf, J, Royall, S, Schrock, C, Schwartz, R, Sharpiro, MJ, Sioson, P, Somberg, LB, Stone, J, Straling, C, Tapscott, W, Tun, F, Turner, W, van Zyl, L, Weireter, L, Wilson, SE, Wright, N, Young, K, Zervos, M & 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, vol. 6, no. 3, pp. 269-282. https://doi.org/10.1089/sur.2005.6.269
Fabian, Timothy C. ; File, Thomas M. ; Embil, John M. ; Krige, Jacobus E J ; Klein, Stanley ; Rose, Andrea ; Melnick, David ; Soto, Norberto E. ; Abbas, Mujahed ; Adler, David ; Bacon, Alfred ; Barbaro, Daniel ; Barr, Lonson ; Becker, Professor ; Bellemare, Jean Francois ; Berkowitz, Kevin ; Berman, Steven ; Brill, Leon ; Bush, Larry ; Caplan, Ellis ; Choudhury, Shanana ; Christou, Nicolas ; Davies, Mark ; DeMarini, Thomas ; Desai, Y. ; Dickey, Thomas ; Dryjski, Maciej ; Eron, Lawrence ; Falanga, Vincent ; Flint, Lewis ; Flynn, William ; Gareca, Marcelo ; Gezon, John ; Ghimenton, Fernando ; Glickman, Marc H. ; Golin, Faldir ; Graham, Donald ; Hampton, R. Moss ; Harding, Godfrey ; Harin, Stuart ; Harrison, Mark ; Ho, Hoi ; Hoffman, Wendall ; Hunt, John ; Irizarry, Lourdes ; Jauregui, Luis ; Khayr, Walid ; Kingman, Robert ; Levine, Donald ; Libman, Michael ; Lotfi, Carlos ; Lucasti, Christopher ; Luterman, Arnold ; Mazuski, John ; McIntyre, Robert ; McMillian, Michael ; Mersey, James H. ; Miller, Miller A. ; Miller, Preston ; Moran, Gregory ; Mushinsky-Tralles, Ann ; Murray, James ; Natalino, Michael ; Nautiyal, Preeti ; Pien, Frances ; Quick, Rhonda ; Ramirez, Ramon ; Reid, Karlene ; Reiter, William ; Richardt, Charles ; Rogers, Selwyn ; Rohlf, Jane ; Royall, Steven ; Schrock, Christian ; Schwartz, Robert ; Sharpiro, Marc J. ; Sioson, Priscilla ; Somberg, Lewis Brain ; Stone, Judy ; Straling, Carlos ; Tapscott, William ; Tun, Fabian ; Turner, William ; van Zyl, Louis ; Weireter, Leonard ; Wilson, Samuel Eric ; Wright, Neilson ; Young, Kim ; Zervos, Marcus ; Zellner, Stephen. / 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. In: Surgical Infections. 2005 ; Vol. 6, No. 3. pp. 269-282.
@article{827a5ccf482e4891bd5179c07a0fd451,
title = "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",
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.",
author = "Fabian, {Timothy C.} and File, {Thomas M.} and Embil, {John M.} and Krige, {Jacobus E J} and Stanley Klein and Andrea Rose and David Melnick and Soto, {Norberto E.} and Mujahed Abbas and David Adler and Alfred Bacon and Daniel Barbaro and Lonson Barr and Professor Becker and Bellemare, {Jean Francois} and Kevin Berkowitz and Steven Berman and Leon Brill and Larry Bush and Ellis Caplan and Shanana Choudhury and Nicolas Christou and Mark Davies and Thomas DeMarini and Y. Desai and Thomas Dickey and Maciej Dryjski and Lawrence Eron and Vincent Falanga and Lewis Flint and William Flynn and Marcelo Gareca and John Gezon and Fernando Ghimenton and Glickman, {Marc H.} and Faldir Golin and Donald Graham and Hampton, {R. Moss} and Godfrey Harding and Stuart Harin and Mark Harrison and Hoi Ho and Wendall Hoffman and John Hunt and Lourdes Irizarry and Luis Jauregui and Walid Khayr and Robert Kingman and Donald Levine and Michael Libman and Carlos Lotfi and Christopher Lucasti and Arnold Luterman and John Mazuski and Robert McIntyre and Michael McMillian and Mersey, {James H.} and Miller, {Miller A.} and Preston Miller and Gregory Moran and Ann Mushinsky-Tralles and James Murray and Michael Natalino and Preeti Nautiyal and Frances Pien and Rhonda Quick and Ramon Ramirez and Karlene Reid and William Reiter and Charles Richardt and Selwyn Rogers and Jane Rohlf and Steven Royall and Christian Schrock and Robert Schwartz and Sharpiro, {Marc J.} and Priscilla Sioson and Somberg, {Lewis Brain} and Judy Stone and Carlos Straling and William Tapscott and Fabian Tun and William Turner and {van Zyl}, Louis and Leonard Weireter and Wilson, {Samuel Eric} and Neilson Wright and Kim Young and Marcus Zervos and Stephen Zellner",
year = "2005",
month = "9",
doi = "10.1089/sur.2005.6.269",
language = "English (US)",
volume = "6",
pages = "269--282",
journal = "Surgical Infections",
issn = "1096-2964",
publisher = "Mary Ann Liebert Inc.",
number = "3",

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TY - JOUR

T1 - Meropenem versus imipenem-cilastatin for the treatment of hospitalized patients with complicated skin and skin structure infections

T2 - Results of multicenter, randomized, double-blind comparative study

AU - Fabian, Timothy C.

AU - File, Thomas M.

AU - Embil, John M.

AU - Krige, Jacobus E J

AU - Klein, Stanley

AU - Rose, Andrea

AU - Melnick, David

AU - Soto, Norberto E.

AU - Abbas, Mujahed

AU - Adler, David

AU - Bacon, Alfred

AU - Barbaro, Daniel

AU - Barr, Lonson

AU - Becker, Professor

AU - Bellemare, Jean Francois

AU - Berkowitz, Kevin

AU - Berman, Steven

AU - Brill, Leon

AU - Bush, Larry

AU - Caplan, Ellis

AU - Choudhury, Shanana

AU - Christou, Nicolas

AU - Davies, Mark

AU - DeMarini, Thomas

AU - Desai, Y.

AU - Dickey, Thomas

AU - Dryjski, Maciej

AU - Eron, Lawrence

AU - Falanga, Vincent

AU - Flint, Lewis

AU - Flynn, William

AU - Gareca, Marcelo

AU - Gezon, John

AU - Ghimenton, Fernando

AU - Glickman, Marc H.

AU - Golin, Faldir

AU - Graham, Donald

AU - Hampton, R. Moss

AU - Harding, Godfrey

AU - Harin, Stuart

AU - Harrison, Mark

AU - Ho, Hoi

AU - Hoffman, Wendall

AU - Hunt, John

AU - Irizarry, Lourdes

AU - Jauregui, Luis

AU - Khayr, Walid

AU - Kingman, Robert

AU - Levine, Donald

AU - Libman, Michael

AU - Lotfi, Carlos

AU - Lucasti, Christopher

AU - Luterman, Arnold

AU - Mazuski, John

AU - McIntyre, Robert

AU - McMillian, Michael

AU - Mersey, James H.

AU - Miller, Miller A.

AU - Miller, Preston

AU - Moran, Gregory

AU - Mushinsky-Tralles, Ann

AU - Murray, James

AU - Natalino, Michael

AU - Nautiyal, Preeti

AU - Pien, Frances

AU - Quick, Rhonda

AU - Ramirez, Ramon

AU - Reid, Karlene

AU - Reiter, William

AU - Richardt, Charles

AU - Rogers, Selwyn

AU - Rohlf, Jane

AU - Royall, Steven

AU - Schrock, Christian

AU - Schwartz, Robert

AU - Sharpiro, Marc J.

AU - Sioson, Priscilla

AU - Somberg, Lewis Brain

AU - Stone, Judy

AU - Straling, Carlos

AU - Tapscott, William

AU - Tun, Fabian

AU - Turner, William

AU - van Zyl, Louis

AU - Weireter, Leonard

AU - Wilson, Samuel Eric

AU - Wright, Neilson

AU - Young, Kim

AU - Zervos, Marcus

AU - Zellner, Stephen

PY - 2005/9

Y1 - 2005/9

N2 - 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.

AB - 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.

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SN - 1096-2964

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