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 McNicoll 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

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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 languageEnglish
Article number88
JournalBMC Infectious Diseases
Volume5
DOIs
Publication statusPublished - 2005 Oct 19

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ASJC Scopus subject areas

  • Infectious Diseases

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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., 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, [88]. https://doi.org/10.1186/1471-2334-5-88