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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EIn a Phase 3 study comparing tedizolid, a second generation oxazolidinone, to linezolid in patients with acute bacterial skin and skin structure infections (ABSSSI), tedizolid phosphate was noninferior and demonstrated high microbiological efficacy compared with linezolid. This article presents a poster [De Anda et al. ICAAC 2012 L1\u20131665] on the outcomes using the the new Food and Drug Administration method for assessing clinical response, programmatic assessment, and the traditional post-treatment investigator assessment.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInfectious Disease Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EBacterial Infections\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EIn a Phase 3 study comparing tedizolid, a second generation oxazolidinone, to linezolid in patients with acute bacterial skin and skin structure infections (ABSSSI), tedizolid phosphate was noninferior and demonstrated high microbiological efficacy compared with linezolid. Carisa De Anda, PharmD, Trius Therapeutics, San Diego, California, USA, presented a poster [De Anda et al. ICAAC 2012 L1\u20131665] on the outcomes using the the new Food and Drug Administration (FDA) method for assessing clinical response, programmatic assessment, and the traditional post-treatment investigator assessment.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThis was a randomized (1:1), double-blind, multicenter study of oral tedizolid phosphate (TDZ) 200 mg QD administered for 6 days versus oral linezolid 600 mg BID for 10 days in adult patients (mean age 43.4 years) with ABSSSI consisting of cellulitis\/erysipelas (41%), infected wounds (29%), and major cutaneous abscesses (30%). Men and women aged \u226518 years with ABSSSI that started at least 7 days before screening were included. To be eligible, patients also had to have at least 1 of the following syndromes: cellulitis with erythema surface area of at least 75 cm\u003Csup\u003E2\u003C\/sup\u003E and at least 1 local sign and symptom (induration, warmth, pain\/tenderness, or swelling), major cutaneous abscess with erythema surface area of at least 75 cm\u003Csup\u003E2\u003C\/sup\u003E and extending at least 5 cm from margin of pus collection and at least 1 local sign and symptom (fluctuance, incision and drainage required, warmth, pain\/tenderness), or wound infection including surgical site infection and trauma with erythema surface area of at least 75 cm\u003Csup\u003E2\u003C\/sup\u003E extending at least 5 cm from margin and purulent drainage. All syndromes required at least 1 regional or systemic sign of infection (lymph node tenderness and increase in volume, fever \u2265 38\u00b0C, WBC \u226510,000 or \u0026lt;4000 or \u0026gt;10% immature neutrophils) and suspected or documented Gram-positive infection.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EA total of 667 patients from North American, Europe, and South America were enrolled in the study. Demographics as well as surface area of lesion (188.3 cm\u003Csup\u003E2\u003C\/sup\u003E in the tedizolid phosphate group vs 190.0 cm\u003Csup\u003E2\u003C\/sup\u003E in the linezolid group) were comparable between the treatment groups.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003ETedizolid phosphate once a day for 6 days was noninferior to linezolid administered twice a day for 10 days for both programmatic outcome (79.5% vs 79.4%; 95% CI, \u22126.1 to 6.2), defined as cessation of spread and no fever at the 48 to 72 hour visit after the first dose of study drug, and investigator\u0027s assessment performed at the 7 to 14 day post-therapy evaluation. In the intention-to-treat population, clinical success (defined by the investigator\u0027s assessment) was 85.5% in the tedizolid group and 86.0% in the linezolid group. There was \u0026gt;80% concordance between the programmatic outcome at the 48 to 72 hour visit and the investigator\u0027s assessment of clinical response at the post-therapy evaluation point.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe Biomarker Consortium of the Foundation for the National Institute of Health [Talbot GH et al. \u003Cem\u003EClin Infect Dis\u003C\/em\u003E 2012] recommended to the FDA that clinical success be defined as \u226520% decrease in lesion size from baseline at the 48 to 72 hour visit without fever included in the endpoint. The results were consistent with the primary outcome with a responder rate of 78% in the tedizolid arm and 76.1 % in the linezolid arm.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe most common baseline infection site pathogen was Gram-positive (63% of patients in both groups). In the tedizolid treatment group, methicillin-resistant \u003Cem\u003EStaphylococcus aureus\u003C\/em\u003E (MRSA; 42.1%) and methicillin-sensitive \u003Cem\u003ES. aureus\u003C\/em\u003E (MSSA; 39.7%) were the most common isolated pathogens. In the linezolid treatment group, similar percentages were reported for MRSA (43.1%) and MSSA (41.6%). The per-patient microbiological response at the post-therapy evaluation is shown in \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E.\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/12903\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/12903\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/12903\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003EPer-Patient Microbiological Response at PTE in the mITT and ME Populations.\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/12\/14\/28.2.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzn9vp\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzn9vp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}