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

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dc.contributor.authorMatthews P.
dc.contributor.authorAlpert M.
dc.contributor.authorRahav G.
dc.contributor.authorRill D.
dc.contributor.authorZito E.
dc.contributor.authorGardiner D.
dc.contributor.authorPedersen R.
dc.contributor.authorBabinchak T.
dc.contributor.authorMcGovern P.C.
dc.contributor.authorArmstrong P.
dc.contributor.authorBailey C.
dc.contributor.authorBerbel G.
dc.contributor.authorBernstein J.
dc.contributor.authorBordon J.
dc.contributor.authorBruno-Murtha L.A.
dc.contributor.authorCaprioli R.
dc.contributor.authorCasey K.
dc.contributor.authorChiang T.
dc.contributor.authorChurukian A.
dc.contributor.authorFlynn W.
dc.contributor.authorGraham D.
dc.contributor.authorHao Z.
dc.contributor.authorKalassian K.
dc.contributor.authorKohler R.
dc.contributor.authorLee J.
dc.contributor.authorLeeds W.
dc.contributor.authorLucasti C.
dc.contributor.authorMalanoski G.
dc.contributor.authorKo T.
dc.contributor.authorMinnaganti V.
dc.contributor.authorMogyoros M.
dc.contributor.authorMorgan B.
dc.contributor.authorMoss C.
dc.contributor.authorMuluk S.
dc.contributor.authorMurthy R.
dc.contributor.authorO'Riordan W.
dc.contributor.authorPien F.
dc.contributor.authorPolk H.
dc.contributor.authorAugustinsky J.B.
dc.contributor.authorSalvaggio M.
dc.contributor.authorSmith L.
dc.contributor.authorSmith R.
dc.contributor.authorScott Stienecker R.
dc.contributor.authorSuh B.
dc.contributor.authorVazquez J.
dc.contributor.authorWeiland D.E.
dc.contributor.authorWessolossky M.
dc.contributor.authorZenilman J.
dc.contributor.authorAbraham C.
dc.contributor.authorNathan R.
dc.contributor.authorSanchez P.
dc.contributor.authorBaird I.
dc.contributor.authorCallahan C.
dc.contributor.authorSchrock C.G.
dc.contributor.authorLau W.
dc.contributor.authorBochan M.R.
dc.contributor.authorSomero M.
dc.contributor.authorKlein S.R.
dc.contributor.authorBellows C.
dc.contributor.authorD'Hooghe A.
dc.contributor.authorCeulemans F.
dc.contributor.authorGaillat J.
dc.contributor.authorGaro B.
dc.contributor.authorEckmann C.
dc.contributor.authorHaier J.
dc.contributor.authorSuter F.
dc.contributor.authorBertani A.
dc.contributor.authorAcin F.
dc.contributor.authorJimenez-Mejias M.E.
dc.contributor.authorBlanes I.
dc.contributor.authorRegueiro D.S.
dc.contributor.authorCakir N.
dc.contributor.authorSaba R.
dc.contributor.authorGiladi M.
dc.contributor.authorKanj-Sharara S.
dc.contributor.authorAhmed al Thaqafi A.O.
dc.contributor.authorNg W.-M.
dc.contributor.authorBurd A.
dc.contributor.authorKurlekar U.
dc.contributor.authorRao N.R.
dc.contributor.authorDevarajan T.
dc.contributor.authorChoi J.
dc.contributor.authorKim Y.
dc.contributor.authorPai H.
dc.contributor.authorPark Y.-S.
dc.contributor.authorKumar S.
dc.contributor.authorChow T.S.
dc.contributor.authorCrisostomo A.
dc.contributor.authorErasmo A.
dc.contributor.authorLow J.
dc.contributor.authorBasson
dc.contributor.authorBreedt J.
dc.contributor.authorMatthews
dc.contributor.authorRoss D.P.
dc.contributor.authorLin H.-H.
dc.contributor.authorLiao C.-H.
dc.contributor.authorKung H.-C.
dc.contributor.authorChinswangwatanakul V.
dc.contributor.authorMalathum K.
dc.contributor.authorTantawichien T.
dc.contributor.authorSergio Ricardo Filho Penteado
dc.contributor.authorCardoso F.
dc.contributor.authorGomez R.F.
dc.contributor.authorVelazquez D.F.
dc.contributor.authorTinoco-Favila J.C.
dc.contributor.authorPoirier A.
dc.contributor.authorValiquette L.
dc.contributor.authorWeiss K.
dc.contributor.authorGrimard D.
dc.contributor.authorEmbil J.M.A.
dc.contributor.authorSanche S.E.
dc.contributor.authorSmith K.
dc.contributor.authorChouinard S.
dc.contributor.authorDolce P.
dc.date.accessioned2024-03-13T01:07:01Z
dc.date.available2024-03-13T01:07:01Z
dc.date.issued2012
dc.description.abstractBackground: 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. © 2012 Matthews et al.; licensee BioMed Central Ltd.
dc.description.volume12
dc.identifier.doi10.1186/1471-2334-12-297
dc.identifier.issn1471-2334
dc.identifier.urihttps://dspace.mackenzie.br/handle/10899/36748
dc.relation.ispartofBMC Infectious Diseases
dc.rightsAcesso Aberto
dc.subject.otherlanguageCSSSI
dc.subject.otherlanguageGlycylcycline
dc.subject.otherlanguageSkin and skin structure infection
dc.subject.otherlanguageTigecycline
dc.titleA randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections
dc.typeArtigo
local.scopus.citations25
local.scopus.eid2-s2.0-84868633430
local.scopus.updated2024-05-01
local.scopus.urlhttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84868633430&origin=inward
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