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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.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\u003Cp id=\u0022p-1\u0022\u003EPooled data from RECLAIM 1 and 2 found that a new combination of antibiotics, incorporating ceftazidime plus avibactam plus metronidazole, was noninferior to meropenem in patients with complicated intra-abdominal infections, with no known safety signals. At the dose studied, the combination was less effective than meropenem to patients with renal impairment at baseline; however, new dosing recommendations are likely to remediate this.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Eceftazidime\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eavibactam\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Emetronidazole\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Emeropenem\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eintra-abdominal infections\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Erenal impairment\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eresistance\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERECLAIM 1 and 2\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Einfectious diseases clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ebacterial infections\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003EThe growing prevalence of third-generation cephalosporin-resistant Enterobacteriaceae and \u003Cem\u003EEscherichia coli\u003C\/em\u003E isolates throughout the world has caused an increase in the utilization of carbapenems. This has led to a resultant surge in carbapenem resistance and has presented an unmet need for antibiotics that will decrease the reliance on carbapenems for treating these infections.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EJohn E. Mazuski, MD, Washington University School of Medicine, St Louis, Missouri, USA, presented pooled data on 2 identical phase 3 studies: RECLAIM 1 [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01499290\u0026amp;atom=%2Fspmdc%2F15%2F48%2F14.atom\u0022\u003ENCT01499290\u003C\/a\u003E] and RECLAIM 2 [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01500239\u0026amp;atom=%2Fspmdc%2F15%2F48%2F14.atom\u0022\u003ENCT01500239\u003C\/a\u003E]. The 2 studies investigated the safety and efficacy of ceftazidime-avibactam (CAZ-AVI) plus metronidazole (MTZ) compared with meropenem (MER) in treating complicated intra-abdominal infections.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003ERECLAIM 1 and 2 originally enrolled 1149 adults with a diagnosis of complicated intra-abdominal infection from 30 countries between March 2012 and April 2014. Patients (n\u2005=\u20051066) were then randomized on a 1:1 basis to receive either CAZ-AVI plus MTZ (n\u2005=\u2005532) or MER (n\u2005=\u2005534) for 5 to 14 days (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). With agreement from both the European Medicines Agency and the FDA, the 2 studies were subsequently combined to form 1 global phase 3 study and analyzed using a single pooled data set. The primary end point of the trial was the clinical cure rate at the test-of-cure visit 28 to 35 days following randomization.\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/48\/14\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Study Design: RECLAIM 1 and RECLAIM 2APACHE, Acute Physiology and Chronic Health Evaluation; cIAI, complicated intra-abdominal infection; EOT, end of treatment; IV, intravenous; LFU, late follow-up; NI, noninferiority; TOC, test of cure.                   aStratified by baseline severity of disease (APACHE II score) and region.Reproduced with permission from JE Mazuski, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1670208737\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;Study Design: RECLAIM 1 and RECLAIM 2APACHE, Acute Physiology and Chronic Health Evaluation; cIAI, complicated intra-abdominal infection; EOT, end of treatment; IV, intravenous; LFU, late follow-up; NI, noninferiority; TOC, test of cure.                   \u0026amp;lt;sup\u0026amp;gt;a\u0026amp;lt;\/sup\u0026amp;gt;Stratified by baseline severity of disease (APACHE II score) and region.Reproduced with permission from JE Mazuski, MD.\u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/48\/14\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/48\/14\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/48\/14\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16613\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\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \u003Cp id=\u0022p-5\u0022 class=\u0022first-child\u0022\u003EStudy Design: RECLAIM 1 and RECLAIM 2\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EAPACHE, Acute Physiology and Chronic Health Evaluation; cIAI, complicated intra-abdominal infection; EOT, end of treatment; IV, intravenous; LFU, late follow-up; NI, noninferiority; TOC, test of cure.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003E\n                  \u003Csup\u003Ea\u003C\/sup\u003EStratified by baseline severity of disease (APACHE II score) and region.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EReproduced with permission from JE Mazuski, MD.\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-9\u0022\u003ENoninferiority was assessed in the modified intention-to-treat (MITT; n\u2005=\u20051043) and clinically evaluable (n\u2005=\u2005826) populations for the European Medicines Agency and the microbiologically modified intention-to-treat (mMITT) (n\u2005=\u2005823) population for the FDA. The level of noninferiority was determined to be met if the lower limit of the 95% confidence interval for the between-group difference was \u0026gt;\u2005\u221212.50%. Adverse events (AEs) and serious AEs, including significant laboratory findings, were compared between groups in the safety population (n\u2005=\u20051058).\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EClinical cure rates at test-of-cure visit in the MITT, clinically evaluable, and mMITT populations are summarized in \u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E. Based on the preset definitions of inferiority, CAZ-AVI plus MTZ was noninferior to MER in all populations. In the mMITT population, CAZ-AVI plus MTZ showed clinical activity in patients infected with CAZ-resistant pathogens, with a clinical cure rate of 83.0% vs 85.9% in patients receiving MER. The treatment difference in this subgroup was \u22123.0% (95% CI, \u221217.9% to 10.6%).\u003C\/p\u003E\u003Cdiv id=\u0022F2\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/48\/14\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Primary Efficacy ResultsSolid line represents sponsor prespecified noninferiority margin of \u0026#x2212;12.5% for the lower limit of the 95% CI. Dashed line represents FDA requirement of \u0026#x2212;10%.CAZ-AVI\u0026#x2005;+\u0026#x2005;MTZ, ceftazidime-avibactam plus metronidazole; CE, clinically evaluable; MER, meropenem; MITT, modified intention to treat; mMITT, microbiologically modified intention to treat; TOC, test of cure.                   aEuropean Medicines Agency co\u0026#x2013;primary analysis population.                   bFDA primary analysis population.Reproduced with permission from JE Mazuski, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1670208737\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;Primary Efficacy ResultsSolid line represents sponsor prespecified noninferiority margin of \u0026#x2212;12.5% for the lower limit of the 95% CI. Dashed line represents FDA requirement of \u0026#x2212;10%.CAZ-AVI\u0026#x2005;+\u0026#x2005;MTZ, ceftazidime-avibactam plus metronidazole; CE, clinically evaluable; MER, meropenem; MITT, modified intention to treat; mMITT, microbiologically modified intention to treat; TOC, test of cure.                   \u0026amp;lt;sup\u0026amp;gt;a\u0026amp;lt;\/sup\u0026amp;gt;European Medicines Agency co\u0026#x2013;primary analysis population.                   \u0026amp;lt;sup\u0026amp;gt;b\u0026amp;lt;\/sup\u0026amp;gt;FDA primary analysis population.Reproduced with permission from JE Mazuski, MD.\u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/48\/14\/F2.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/48\/14\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/48\/14\/F2.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16614\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\u003Cdiv class=\u0022fig-caption\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 2.\u003C\/span\u003E \u003Cp id=\u0022p-11\u0022 class=\u0022first-child\u0022\u003EPrimary Efficacy Results\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003ESolid line represents sponsor prespecified noninferiority margin of \u221212.5% for the lower limit of the 95% CI. Dashed line represents FDA requirement of \u221210%.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003ECAZ-AVI\u2005+\u2005MTZ, ceftazidime-avibactam plus metronidazole; CE, clinically evaluable; MER, meropenem; MITT, modified intention to treat; mMITT, microbiologically modified intention to treat; TOC, test of cure.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003E\n                  \u003Csup\u003Ea\u003C\/sup\u003EEuropean Medicines Agency co\u2013primary analysis population.\u003C\/p\u003E\u003Cp id=\u0022p-15\u0022\u003E\n                  \u003Csup\u003Eb\u003C\/sup\u003EFDA primary analysis population.\u003C\/p\u003E\u003Cp id=\u0022p-16\u0022\u003EReproduced with permission from JE Mazuski, MD.\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-17\u0022\u003EThe rate of AEs with CAZ-AVI plus MTZ was 45.9%, compared with 42.9% with MER, with serious AE rates of 7.9% and 7.6%, respectively. The most frequently reported AEs following treatment with CAZ-AVI plus MTZ were diarrhea, nausea, vomiting, and fever.\u003C\/p\u003E\u003Cp id=\u0022p-18\u0022\u003EProf Mazuski highlighted a specific subgroup of patients with moderate renal impairment at baseline. The clinical cure rates in these patients were lower in the CAZ-AVI plus MTZ group compared with the MER group (48.8% vs 74.4%; between-group percentage, \u221225.6; 95% CI, \u221244.53 to \u22124.78). However, because approximately two-thirds of these patients showed rapid improvement in creatinine clearance within 48 to 72 hours of dosing, the lower cure rates may reflect underdosing of the CAZ-AVI plus MTZ group in the first critical days of the study. According to Prof Mazuski, new dosing adjustments are forthcoming for patients with moderate renal impairment.\u003C\/p\u003E\u003Cp id=\u0022p-19\u0022\u003EIn summary, CAZ-AVI plus MTZ was noninferior to MER in the treatment of patients with complicated intra-abdominal infection and had a safety profile consistent with the known profiles of CAZ and MTZ. The combination therapy produced high response rates against key pathogens and against ceftazidime-resistant pathogens.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\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\/15\/48\/14.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_figures.js?nzllxf\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_openurl.js?nzllxf\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}