A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections

Peter Matthews, Marc Alpert, Galia Rahav, Denise Rill, Edward Zito, David Gardiner, Ron Pedersen, Timothy Babinchak, Paul C. McGovern, Peter Armstrong, Charles Bailey, German Berbel, Jack Bernstein, Jose Bordon, Lou Ann Bruno-Murtha, Russell Caprioli, Kathleen Casey, Tom Chiang, Allan Churukian, William FlynnDonald Graham, Zijun Hao, Kenneth Kalassian, Richard Kohler, Juliet Lee, William Leeds, Christopher Lucasti, Gregory Malanoski, Tien Ko, Venkat Minnaganti, Miguel Mogyoros, Bill Morgan, Charles Moss, Satish Muluk, Rekha Murthy, William O'Riordan, Francis Pien, Hiram Polk, James B. Augustinsky, Michelle Salvaggio, Leon Smith, Raymond Smith, R. Scott Stienecker, Byungse Suh, Jose Antonio Vazquez, Dennis E. Weiland, Mireya Wessolossky, Jonathan Zenilman, Carl Abraham, Richard Nathan, Phillip Sanchez, Ian Baird, Charles Callahan, Christian G. Schrock, William Lau, Markian R. Bochan, Michael Somero, Stanley R. Klein, Charles Bellows, Annick D'Hooghe, Françoise Ceulemans, Jacques Gaillat, Bernard Garo, Christian Eckmann, Joerg Haier, Fredy Suter, Aldo Bertani, Francisco Acin, Manuel E. Jiménez-Mejías, Ignacio Blanes, Dolores Sousa Regueiro, Nedim Cakir, Rabin Saba, Michael Giladi, Souha Kanj-Sharara, Abdulhakeem Okab Ahmed al Thaqafi, Wai Man Ng, Andrew Burd, Utkrant Kurlekar, N. Raghupathi Rao, T. Devarajan, Junyong Choi, Yeonsook Kim, Hyunjoo Pai, Yoon Soo Park, Suresh Kumar, Ting Soo Chow, Armando Crisostomo, Alex Erasmo, Jenny Low, M. M. Basson, Johannes Breedt, P. A. Matthews, D. P. Ross, His Hsun Lin, Chun Hsing Liao, Hsiang Chi Kung, Vitoon Chinswangwatanakul, Kumthorn Malathum, Terapong Tantawichien, Ricardo Filho Penteado Sergio Ricardo Filho Penteado, Fernando Cardoso, Roosevelt Fajardo Gomez, David Fernandez Velazquez, Juan Carlos Tinoco-Favila, Andre Poirier, Louis Valiquette, Karl Weiss, Doria Grimard, John M.A. Embil, Steven E. Sanche, Ken Smith, Sylvain Chouinard, Patrick Dolcé

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Abstract

Background: Complicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality.Methods: In this phase 3b/4 parallel, randomized, open-label, comparative study, 531 subjects with cSSSI received tigecycline (100 mg initial dose, then 50 mg intravenously every 12 hrs) or ampicillin-sulbactam 1.5-3 g IV every 6 hrs or amoxicillin-clavulanate 1.2 g IV every 6-8 hrs. Vancomycin could be added at the discretion of the investigator to the comparator arm if methicillin-resistant Staphylococcus aureus (MRSA) was confirmed or suspected within 72 hrs of enrollment. The primary endpoint was clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit. Microbiologic response and safety were also assessed. The modified intent-to-treat (mITT) population comprised 531 subjects (tigecycline, n = 268; comparator, n = 263) and 405 were clinically evaluable (tigecycline, n = 209; comparator, n = 196).Results: In the CE population, 162/209 (77.5%) tigecycline-treated subjects and 152/196 (77.6%) comparator-treated subjects were clinically cured (difference 0.0; 95% confidence interval [CI]: -8.7, 8.6). The eradication rates at the subject level for the microbiologically evaluable (ME) population were 79.2% in the tigecycline treatment group and 76.8% in the comparator treatment group (difference 2.4; 95% CI: -9.6, 14.4) at the TOC assessment. Nausea, vomiting, and diarrhea rates were higher in the tigecycline group.Conclusions: Tigecycline was generally safe and effective in the treatment of cSSSIs.Trial registration: ClinicalTrials.gov NCT00368537.

Original languageEnglish (US)
Article number297
JournalBMC Infectious Diseases
Volume12
DOIs
Publication statusPublished - Nov 12 2012

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Keywords

  • CSSSI
  • Glycylcycline
  • Skin and skin structure infection
  • Tigecycline

ASJC Scopus subject areas

  • Infectious Diseases

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