Produção Nacional
Revisado por pares
A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections
2012; BioMed Central; Volume: 12; Issue: 1 Linguagem: Inglês
10.1186/1471-2334-12-297
ISSN1471-2334
AutoresPeter A. Matthews, Marc Alpert, Galia Rahav, Denise Rill, Edward T. Zito, David Gardiner, Ron Pedersen, Timothy Babinchak, Paul C. McGovern, Peter Armstrong, L. Charles Bailey, German Berbel, Jack Bernstein, José Bordón, Lou Ann Bruno‐Murtha, Russell Caprioli, Kathleen Casey, Tom Chiang, Allan Churukian, William J. Flynn, Donald R. Graham, Hao Zi-jun, Kenneth Kalassian, Richard Köhler, Juliet Lee, William Leeds, Christopher Lucasti, G J Malanoski, Tien C. Ko, Venkat R. Minnaganti, Miguel Mogyoros, Bill Morgan, Charles M. Moss, Satish C. Muluk, Rekha Murthy, William O’Riordan, Francis D. Pien, Hiram C. Polk, James B. Augustinsky, Michelle Salvaggio, Leon G. Smith, Raymond P. Smith, Roger Scott Stienecker, Byungse Suh, José A. Vázquez, Dennis E. Weiland, Mireya Wessolossky, Jonathan M. Zenilman, Carl Halladay Abraham, Richard Nathan, Phillip J. Sanchez, Ian M. Baird, Charles Callahan, Christian G. Schrock, William Lau, Markian R. Bochan, Michael Somero, Stanley R. Klein, Charles F. Bellows, Annick D'Hooghe, F. Ceulemans, J. Gaillat, B. Garo, Christian Eckmann, Jörg Haier, Fredy Suter, Aldo Bertani, Francisco Acín, Jiménez-Mejías Me, Ignacio Blanes, Dolores Sousa Regueiro, Nedim Çakır, Rabin Saba, Michael Giladi, Souha Kanj‐Sharara, Abdulhakeem Okab Ahmed al Thaqafi, Wai Man Ng, Andrew Burd, Utkrant Kurlekar, Nalini Rao, T.V. Devarajan, Jun Yong Choi, Kim Ys, Hyunjoo Pai, Yoon Soo Park, Suresh Kumar, Ting Soo Chow, Armando Crisostomo, Alex Erasmo, Jenny G. Low, Matthys M de V Basson, Johannes Breedt, Peter A. Matthews, Douglas Patrick Ross, His Hsun Lin, Chun‐Hsing Liao, Hsiang‐Chi Kung, Vitoon Chinswangwatanakul, Kumthorn Malathum, Terapong Tantawichien, Ricardo Filho Penteado Sergio Ricardo Filho Penteado, Fernando C. Cardoso, Roosevelt Fajardo Gomez, David Fernandez Velazquez, Juan Carlos Tinoco-Fávila, André Poirier, Louis Valiquette, Karl Heinz Weiss, Doria Grimard, John M. Embil, Stephen Sanche, Ken Smith, Sylvain Chouinard, Patrick Dolcé,
Tópico(s)Bacterial Identification and Susceptibility Testing
ResumoComplicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality. 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). 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. Tigecycline was generally safe and effective in the treatment of cSSSIs. ClinicalTrials.gov NCT00368537
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