A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID numbers: 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744]

María Eugenia Oliva; Arcot Rekha; Albert Yellin; Jacyr Pasternak; Maria Campos; Gilbert M. Rose; Timothy Babinchak; Evelyn J. Ellis-Grosse; Evan Loh; Fathi Abuzgaya; Louis H. Alarcon; Marc Alpert; Eduardo G. Arathoon; Rebeca Georgina Northland Areyuna; Annadan C. Ashok; Jeffrey A. Bailey; Ian Mc Nicoll Baird; Philip S. Barie; M. Y. Bapaye; Robert W. Beart; Jean François Bellemare; Guillermo Alberto Benchetrit; German Berbel; Carlos Enrique Bergallo; Joaquin Bermejo; Thomas B. Berne; Marcela Alicia Vera Blanch; John M.A. Bohnen; Patricia Brown; Maria Isabel Campos; Iris Lorena Cazali; Nicolas V. Christou; Daniel Jorge Curcio; Alexey Datsenko; Mario Del Castillo; E. Patchen Dellinger; Sanjay P. Desmukh; Puneet Dhar; Julia Garcia-Diaz; John W. Drover; John M.A. Embil; Zilvinas Endzinas; David Evans; Peter Fomin; Joseph Fraiz; Amalia Rodriquez French; Gary E. Garber; Doria Grimard; Gene Grindlinger; Virsing Punabhai Hathila; Ernesto Julio Jakob; Abel Jasovich; A. Mark Joffe; Ashok Tarachandji Kamble; Ricardo Eiji Kawamoto; Paul Kearney; Min Ja Kim; Yang Soo Kim; Robert G. Kingman; Stanley R. Klein; We Je Ko; William K.K. Lau; Patrick C. Lee; Dawei Liu; Carlos Lovesio; John Mazuski; Charles Morrow; Chau Nguyen; Maria Eugenia Oliva; Maria Costa Orlando; Guilermo M. Ruiz-Palacios; Eduardo Parra-Davila; Andrejs Pavars; André Poirer; Germain Poirer; Guntars Pupelis; K. Ramachandra Pai; Hariharan Ramesh; M. K. Ramesh; Arturas Razbadauskas; Arcot Rekha; Ronald D. Robertson; Orio D. Rotstein; Rajkumar Janavicularm Sankaran; Ragulagedda Adikesava Sastry; Yan Shen Shan; Rabih Shalloum; Stephen D. Shafran; Jae Hoon Song; Yaoqing Tang; Osvaldo Teglia; Jüri Teras; Shirin Towfigh; Tiit Vaasna; Walter Vasen; Carlos Rodolfo; Mejia Villatoro; Ramses Wassef; Junmin Wei

doi:10.1186/1471-2334-5-88

A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID numbers: 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744]

María Eugenia Oliva, Arcot Rekha, Albert Yellin, Jacyr Pasternak, Maria Campos, Gilbert M. Rose, Timothy Babinchak, Evelyn J. Ellis-Grosse, Evan Loh, Fathi Abuzgaya, Louis H. Alarcon, Marc Alpert, Eduardo G. Arathoon, Rebeca Georgina Northland Areyuna, Annadan C. Ashok, Jeffrey A. Bailey, Ian Mc Nicoll Baird, Philip S. Barie, M. Y. Bapaye, Robert W. BeartJean François Bellemare, Guillermo Alberto Benchetrit, German Berbel, Carlos Enrique Bergallo, Joaquin Bermejo, Thomas B. Berne, Marcela Alicia Vera Blanch, John M.A. Bohnen, Patricia Brown, Maria Isabel Campos, Iris Lorena Cazali, Nicolas V. Christou, Daniel Jorge Curcio, Alexey Datsenko, Mario Del Castillo, E. Patchen Dellinger, Sanjay P. Desmukh, Puneet Dhar, Julia Garcia-Diaz, John W. Drover, John M.A. Embil, Zilvinas Endzinas, David Evans, Peter Fomin, Joseph Fraiz, Amalia Rodriquez French, Gary E. Garber, Doria Grimard, Gene Grindlinger, Virsing Punabhai Hathila, Ernesto Julio Jakob, Abel Jasovich, A. Mark Joffe, Ashok Tarachandji Kamble, Ricardo Eiji Kawamoto, Paul Kearney, Min Ja Kim, Yang Soo Kim, Robert G. Kingman, Stanley R. Klein, We Je Ko, William K.K. Lau, Patrick C. Lee, Dawei Liu, Carlos Lovesio, John Mazuski, Charles Morrow, Chau Nguyen, Maria Eugenia Oliva, Maria Costa Orlando, Guilermo M. Ruiz-Palacios, Eduardo Parra-Davila, Andrejs Pavars, André Poirer, Germain Poirer, Guntars Pupelis, K. Ramachandra Pai, Hariharan Ramesh, M. K. Ramesh, Arturas Razbadauskas, Arcot Rekha, Ronald D. Robertson, Orio D. Rotstein, Rajkumar Janavicularm Sankaran, Ragulagedda Adikesava Sastry, Yan Shen Shan, Rabih Shalloum, Stephen D. Shafran, Jae Hoon Song, Yaoqing Tang, Osvaldo Teglia, Jüri Teras, Shirin Towfigh, Tiit Vaasna, Walter Vasen, Carlos Rodolfo, Mejia Villatoro, Ramses Wassef, Junmin Wei

Section of Acute and Critical Care Surgery

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158 Scopus citations

Abstract

Background: Complicated intra-abdominal infections (cIAI) remain challenging to treat because of their polymicrobial etiology including multi-drug resistant bacteria. The efficacy and safety of tigecycline, an expanded broad-spectrum glycylcycline antibiotic, was compared with imipenem/cilastatin (IMI/CIS) in patients with cIAI. Methods: A prospective, double-blind, multinational trial was conducted in which patients with cIAI randomly received intravenous (IV) tigecycline (100 mg initial dose, then 50 mg every 12 hours [q12h]) or IV IMI/CIS (500/500 mg q6h or adjusted for renal dysfunction) for 5 to 14 days. Clinical response at the test-of-cure (TOC) visit (14-35 days after therapy) for microbiologically evaluable (ME) and microbiological modified intent-to-treat (m-mITT) populations were the coprimary efficacy endpoint populations. Results: A total of 825 patients received ≥ 1 dose of study drug. The primary diagnoses for the ME group were complicated appendicitis (59%), and intestinal (8.8%) and gastric/duodenal perforations (4.6%). For the ME group, clinical cure rates at TOC were 80.6% (199/247) for tigecycline versus 82.4% (210/255) for IMI/CIS (95% CI -8.4, 5.1 for non-inferiority tigecycline versus IMI/CIS). Corresponding clinical cure rates within the m-mITT population were 73.5% (227/309) for tigecycline versus 78.2% (244/312) for IMI/CIS (95% CI -11.0, 2.5). Nausea (31.0% tigecycline, 24.8% IMI/CIS [P=0.052]), vomiting (25.7% tigecycline, 19.4% IMI/CIS [P=0.037]), and diarrhea (21.3% tigecycline, 18.9% IMI/CIS [P=0.435]) were the most frequently reported adverse events. Conclusions: This study demonstrates that tigecycline is as efficacious imipenem/cilastatin in the treatment of patients with cIAI.

Original language	English
Article number	88
Journal	BMC Infectious Diseases
Volume	5
DOIs	https://doi.org/10.1186/1471-2334-5-88
State	Published - Oct 19 2005

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Oliva, M. E., Rekha, A., Yellin, A., Pasternak, J., Campos, M., Rose, G. M., Babinchak, T., Ellis-Grosse, E. J., Loh, E., Abuzgaya, F., Alarcon, L. H., Alpert, M., Arathoon, E. G., Northland Areyuna, R. G., Ashok, A. C., Bailey, J. A., Baird, I. M. N., Barie, P. S., Bapaye, M. Y., ... Wei, J. (2005). A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID numbers: 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744]. BMC Infectious Diseases, 5, Article 88. https://doi.org/10.1186/1471-2334-5-88

@article{a915ac0e661b477caadc27f211f7cfc7,

title = "A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID numbers: 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744]",

abstract = "Background: Complicated intra-abdominal infections (cIAI) remain challenging to treat because of their polymicrobial etiology including multi-drug resistant bacteria. The efficacy and safety of tigecycline, an expanded broad-spectrum glycylcycline antibiotic, was compared with imipenem/cilastatin (IMI/CIS) in patients with cIAI. Methods: A prospective, double-blind, multinational trial was conducted in which patients with cIAI randomly received intravenous (IV) tigecycline (100 mg initial dose, then 50 mg every 12 hours [q12h]) or IV IMI/CIS (500/500 mg q6h or adjusted for renal dysfunction) for 5 to 14 days. Clinical response at the test-of-cure (TOC) visit (14-35 days after therapy) for microbiologically evaluable (ME) and microbiological modified intent-to-treat (m-mITT) populations were the coprimary efficacy endpoint populations. Results: A total of 825 patients received ≥ 1 dose of study drug. The primary diagnoses for the ME group were complicated appendicitis (59%), and intestinal (8.8%) and gastric/duodenal perforations (4.6%). For the ME group, clinical cure rates at TOC were 80.6% (199/247) for tigecycline versus 82.4% (210/255) for IMI/CIS (95% CI -8.4, 5.1 for non-inferiority tigecycline versus IMI/CIS). Corresponding clinical cure rates within the m-mITT population were 73.5% (227/309) for tigecycline versus 78.2% (244/312) for IMI/CIS (95% CI -11.0, 2.5). Nausea (31.0% tigecycline, 24.8% IMI/CIS [P=0.052]), vomiting (25.7% tigecycline, 19.4% IMI/CIS [P=0.037]), and diarrhea (21.3% tigecycline, 18.9% IMI/CIS [P=0.435]) were the most frequently reported adverse events. Conclusions: This study demonstrates that tigecycline is as efficacious imipenem/cilastatin in the treatment of patients with cIAI.",

author = "Oliva, {Mar{\'i}a Eugenia} and Arcot Rekha and Albert Yellin and Jacyr Pasternak and Maria Campos and Rose, {Gilbert M.} and Timothy Babinchak and Ellis-Grosse, {Evelyn J.} and Evan Loh and Fathi Abuzgaya and Alarcon, {Louis H.} and Marc Alpert and Arathoon, {Eduardo G.} and {Northland Areyuna}, {Rebeca Georgina} and Ashok, {Annadan C.} and Bailey, {Jeffrey A.} and Baird, {Ian Mc Nicoll} and Barie, {Philip S.} and Bapaye, {M. Y.} and Beart, {Robert W.} and Bellemare, {Jean Fran{\c c}ois} and Benchetrit, {Guillermo Alberto} and German Berbel and Bergallo, {Carlos Enrique} and Joaquin Bermejo and Berne, {Thomas B.} and {Vera Blanch}, {Marcela Alicia} and Bohnen, {John M.A.} and Patricia Brown and Campos, {Maria Isabel} and Cazali, {Iris Lorena} and Christou, {Nicolas V.} and Curcio, {Daniel Jorge} and Alexey Datsenko and {Del Castillo}, Mario and Dellinger, {E. Patchen} and Desmukh, {Sanjay P.} and Puneet Dhar and Julia Garcia-Diaz and Drover, {John W.} and Embil, {John M.A.} and Zilvinas Endzinas and David Evans and Peter Fomin and Joseph Fraiz and French, {Amalia Rodriquez} and Garber, {Gary E.} and Doria Grimard and Gene Grindlinger and Hathila, {Virsing Punabhai} and Jakob, {Ernesto Julio} and Abel Jasovich and Joffe, {A. Mark} and Kamble, {Ashok Tarachandji} and Kawamoto, {Ricardo Eiji} and Paul Kearney and Kim, {Min Ja} and Kim, {Yang Soo} and Kingman, {Robert G.} and Klein, {Stanley R.} and Ko, {We Je} and Lau, {William K.K.} and Lee, {Patrick C.} and Dawei Liu and Carlos Lovesio and John Mazuski and Charles Morrow and Chau Nguyen and Oliva, {Maria Eugenia} and Orlando, {Maria Costa} and Ruiz-Palacios, {Guilermo M.} and Eduardo Parra-Davila and Andrejs Pavars and Andr{\'e} Poirer and Germain Poirer and Guntars Pupelis and Pai, {K. Ramachandra} and Hariharan Ramesh and Ramesh, {M. K.} and Arturas Razbadauskas and Arcot Rekha and Robertson, {Ronald D.} and Rotstein, {Orio D.} and Sankaran, {Rajkumar Janavicularm} and Sastry, {Ragulagedda Adikesava} and Shan, {Yan Shen} and Rabih Shalloum and Shafran, {Stephen D.} and Song, {Jae Hoon} and Yaoqing Tang and Osvaldo Teglia and J{\"u}ri Teras and Shirin Towfigh and Tiit Vaasna and Walter Vasen and Carlos Rodolfo and Mejia Villatoro and Ramses Wassef and Junmin Wei",

year = "2005",

month = oct,

day = "19",

doi = "10.1186/1471-2334-5-88",

language = "English",

volume = "5",

journal = "BMC Infectious Diseases",

issn = "1471-2334",

}

Oliva, ME, Rekha, A, Yellin, A, Pasternak, J, Campos, M, Rose, GM, Babinchak, T, Ellis-Grosse, EJ, Loh, E, Abuzgaya, F, Alarcon, LH, Alpert, M, Arathoon, EG, Northland Areyuna, RG, Ashok, AC, Bailey, JA, Baird, IMN, Barie, PS, Bapaye, MY, Beart, RW, Bellemare, JF, Benchetrit, GA, Berbel, G, Bergallo, CE, Bermejo, J, Berne, TB, Vera Blanch, MA, Bohnen, JMA, Brown, P, Campos, MI, Cazali, IL, Christou, NV, Curcio, DJ, Datsenko, A, Del Castillo, M, Dellinger, EP, Desmukh, SP, Dhar, P, Garcia-Diaz, J, Drover, JW, Embil, JMA, Endzinas, Z, Evans, D, Fomin, P, Fraiz, J, French, AR, Garber, GE, Grimard, D, Grindlinger, G, Hathila, VP, Jakob, EJ, Jasovich, A, Joffe, AM, Kamble, AT, Kawamoto, RE, Kearney, P, Kim, MJ, Kim, YS, Kingman, RG, Klein, SR, Ko, WJ, Lau, WKK, Lee, PC, Liu, D, Lovesio, C, Mazuski, J, Morrow, C, Nguyen, C, Oliva, ME, Orlando, MC, Ruiz-Palacios, GM, Parra-Davila, E, Pavars, A, Poirer, A, Poirer, G, Pupelis, G, Pai, KR, Ramesh, H, Ramesh, MK, Razbadauskas, A, Rekha, A, Robertson, RD, Rotstein, OD, Sankaran, RJ, Sastry, RA, Shan, YS, Shalloum, R, Shafran, SD, Song, JH, Tang, Y, Teglia, O, Teras, J, Towfigh, S, Vaasna, T, Vasen, W, Rodolfo, C, Villatoro, M, Wassef, R & Wei, J 2005, 'A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID numbers: 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744]', BMC Infectious Diseases, vol. 5, 88. https://doi.org/10.1186/1471-2334-5-88

A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID numbers: 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744]. / Oliva, María Eugenia; Rekha, Arcot; Yellin, Albert et al.
In: BMC Infectious Diseases, Vol. 5, 88, 19.10.2005.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID numbers

T2 - 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744]

AU - Oliva, María Eugenia

AU - Rekha, Arcot

AU - Yellin, Albert

AU - Pasternak, Jacyr

AU - Campos, Maria

AU - Rose, Gilbert M.

AU - Babinchak, Timothy

AU - Ellis-Grosse, Evelyn J.

AU - Loh, Evan

AU - Abuzgaya, Fathi

AU - Alarcon, Louis H.

AU - Alpert, Marc

AU - Arathoon, Eduardo G.

AU - Northland Areyuna, Rebeca Georgina

AU - Ashok, Annadan C.

AU - Bailey, Jeffrey A.

AU - Baird, Ian Mc Nicoll

AU - Barie, Philip S.

AU - Bapaye, M. Y.

AU - Beart, Robert W.

AU - Bellemare, Jean François

AU - Benchetrit, Guillermo Alberto

AU - Berbel, German

AU - Bergallo, Carlos Enrique

AU - Bermejo, Joaquin

AU - Berne, Thomas B.

AU - Vera Blanch, Marcela Alicia

AU - Bohnen, John M.A.

AU - Brown, Patricia

AU - Campos, Maria Isabel

AU - Cazali, Iris Lorena

AU - Christou, Nicolas V.

AU - Curcio, Daniel Jorge

AU - Datsenko, Alexey

AU - Del Castillo, Mario

AU - Dellinger, E. Patchen

AU - Desmukh, Sanjay P.

AU - Dhar, Puneet

AU - Garcia-Diaz, Julia

AU - Drover, John W.

AU - Embil, John M.A.

AU - Endzinas, Zilvinas

AU - Evans, David

AU - Fomin, Peter

AU - Fraiz, Joseph

AU - French, Amalia Rodriquez

AU - Garber, Gary E.

AU - Grimard, Doria

AU - Grindlinger, Gene

AU - Hathila, Virsing Punabhai

AU - Jakob, Ernesto Julio

AU - Jasovich, Abel

AU - Joffe, A. Mark

AU - Kamble, Ashok Tarachandji

AU - Kawamoto, Ricardo Eiji

AU - Kearney, Paul

AU - Kim, Min Ja

AU - Kim, Yang Soo

AU - Kingman, Robert G.

AU - Klein, Stanley R.

AU - Ko, We Je

AU - Lau, William K.K.

AU - Lee, Patrick C.

AU - Liu, Dawei

AU - Lovesio, Carlos

AU - Mazuski, John

AU - Morrow, Charles

AU - Nguyen, Chau

AU - Oliva, Maria Eugenia

AU - Orlando, Maria Costa

AU - Ruiz-Palacios, Guilermo M.

AU - Parra-Davila, Eduardo

AU - Pavars, Andrejs

AU - Poirer, André

AU - Poirer, Germain

AU - Pupelis, Guntars

AU - Pai, K. Ramachandra

AU - Ramesh, Hariharan

AU - Ramesh, M. K.

AU - Razbadauskas, Arturas

AU - Rekha, Arcot

AU - Robertson, Ronald D.

AU - Rotstein, Orio D.

AU - Sankaran, Rajkumar Janavicularm

AU - Sastry, Ragulagedda Adikesava

AU - Shan, Yan Shen

AU - Shalloum, Rabih

AU - Shafran, Stephen D.

AU - Song, Jae Hoon

AU - Tang, Yaoqing

AU - Teglia, Osvaldo

AU - Teras, Jüri

AU - Towfigh, Shirin

AU - Vaasna, Tiit

AU - Vasen, Walter

AU - Rodolfo, Carlos

AU - Villatoro, Mejia

AU - Wassef, Ramses

AU - Wei, Junmin

PY - 2005/10/19

Y1 - 2005/10/19

N2 - Background: Complicated intra-abdominal infections (cIAI) remain challenging to treat because of their polymicrobial etiology including multi-drug resistant bacteria. The efficacy and safety of tigecycline, an expanded broad-spectrum glycylcycline antibiotic, was compared with imipenem/cilastatin (IMI/CIS) in patients with cIAI. Methods: A prospective, double-blind, multinational trial was conducted in which patients with cIAI randomly received intravenous (IV) tigecycline (100 mg initial dose, then 50 mg every 12 hours [q12h]) or IV IMI/CIS (500/500 mg q6h or adjusted for renal dysfunction) for 5 to 14 days. Clinical response at the test-of-cure (TOC) visit (14-35 days after therapy) for microbiologically evaluable (ME) and microbiological modified intent-to-treat (m-mITT) populations were the coprimary efficacy endpoint populations. Results: A total of 825 patients received ≥ 1 dose of study drug. The primary diagnoses for the ME group were complicated appendicitis (59%), and intestinal (8.8%) and gastric/duodenal perforations (4.6%). For the ME group, clinical cure rates at TOC were 80.6% (199/247) for tigecycline versus 82.4% (210/255) for IMI/CIS (95% CI -8.4, 5.1 for non-inferiority tigecycline versus IMI/CIS). Corresponding clinical cure rates within the m-mITT population were 73.5% (227/309) for tigecycline versus 78.2% (244/312) for IMI/CIS (95% CI -11.0, 2.5). Nausea (31.0% tigecycline, 24.8% IMI/CIS [P=0.052]), vomiting (25.7% tigecycline, 19.4% IMI/CIS [P=0.037]), and diarrhea (21.3% tigecycline, 18.9% IMI/CIS [P=0.435]) were the most frequently reported adverse events. Conclusions: This study demonstrates that tigecycline is as efficacious imipenem/cilastatin in the treatment of patients with cIAI.

AB - Background: Complicated intra-abdominal infections (cIAI) remain challenging to treat because of their polymicrobial etiology including multi-drug resistant bacteria. The efficacy and safety of tigecycline, an expanded broad-spectrum glycylcycline antibiotic, was compared with imipenem/cilastatin (IMI/CIS) in patients with cIAI. Methods: A prospective, double-blind, multinational trial was conducted in which patients with cIAI randomly received intravenous (IV) tigecycline (100 mg initial dose, then 50 mg every 12 hours [q12h]) or IV IMI/CIS (500/500 mg q6h or adjusted for renal dysfunction) for 5 to 14 days. Clinical response at the test-of-cure (TOC) visit (14-35 days after therapy) for microbiologically evaluable (ME) and microbiological modified intent-to-treat (m-mITT) populations were the coprimary efficacy endpoint populations. Results: A total of 825 patients received ≥ 1 dose of study drug. The primary diagnoses for the ME group were complicated appendicitis (59%), and intestinal (8.8%) and gastric/duodenal perforations (4.6%). For the ME group, clinical cure rates at TOC were 80.6% (199/247) for tigecycline versus 82.4% (210/255) for IMI/CIS (95% CI -8.4, 5.1 for non-inferiority tigecycline versus IMI/CIS). Corresponding clinical cure rates within the m-mITT population were 73.5% (227/309) for tigecycline versus 78.2% (244/312) for IMI/CIS (95% CI -11.0, 2.5). Nausea (31.0% tigecycline, 24.8% IMI/CIS [P=0.052]), vomiting (25.7% tigecycline, 19.4% IMI/CIS [P=0.037]), and diarrhea (21.3% tigecycline, 18.9% IMI/CIS [P=0.435]) were the most frequently reported adverse events. Conclusions: This study demonstrates that tigecycline is as efficacious imipenem/cilastatin in the treatment of patients with cIAI.

UR - http://www.scopus.com/inward/record.url?scp=27744520632&partnerID=8YFLogxK

U2 - 10.1186/1471-2334-5-88

DO - 10.1186/1471-2334-5-88

M3 - Article

C2 - 16236177

AN - SCOPUS:27744520632

SN - 1471-2334

VL - 5

JO - BMC Infectious Diseases

JF - BMC Infectious Diseases

M1 - 88

ER -

A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID numbers: 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744]

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