{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T00:24:00Z","timestamp":1779236640600,"version":"3.51.4"},"reference-count":36,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2020,11,13]],"date-time":"2020-11-13T00:00:00Z","timestamp":1605225600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Tetraphase Pharmaceuticals Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,12,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The increasing prevalence of obesity worldwide merits an examination of the efficacy and safety profiles of agents dosed by weight.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Data for patients (n\u2005=\u20051037) were obtained from the pooled IGNITE1 and IGNITE4 randomized double-blind trials in which patients with complicated intra-abdominal infections received eravacycline 1 mg\/kg (actual body weight [ABW]) every 12 hours or comparator (ertapenem 1 g every 24 hours or meropenem 1 g every 8 hours) intravenously. This post hoc analysis evaluated clinical cure rates, adverse events, and drug discontinuation rates stratified by body mass index (BMI) categories of BMI &amp;gt;40 kg\/m2 (Obese, Class III), BMI 35\u201339.9 kg\/m2 (Obese, Class II), BMI 30\u201334.9 kg\/m2 (Obese, Class I), BMI 25\u201329.9 kg\/m2 (Overweight), BMI 18.5\u201324.9 kg\/m2 (Healthy weight), and BMI &amp;lt;18.5 kg\/m2 (Underweight).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Clinical cure rates were high across BMI categories and ranged from 82% to 94% in the eravacycline group and 88.5%\u2013100% in the comparator group. Similar cure rates were observed among eravacycline-treated healthy weight (126\/134; 94%), overweight (127\/146; 87%), and obese (BMI\u2005\u226530 kg\/m2; 110\/129; 85.3%) patients. In the comparator group, a similar proportion of patients demonstrated clinical response (healthy weight [132\/145; 91%], overweight [130\/144; 90.3%], and obese [115\/129; 89.1%]). Of the treatment-emergent adverse events that occurred in eravacycline-treated obese patients, a larger proportion were gastrointestinal-related (ie, nausea and vomiting); however, discontinuation rates were low and similar between eravacycline and carbapenems.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This post hoc analysis demonstrates the therapeutic utility and acceptable safety profile of eravacycline dosed by ABW in obese patients (BMI\u2005\u226530 kg\/m2).<\/jats:p><\/jats:sec>","DOI":"10.1093\/ofid\/ofaa548","type":"journal-article","created":{"date-parts":[[2020,11,13]],"date-time":"2020-11-13T16:16:14Z","timestamp":1605284174000},"source":"Crossref","is-referenced-by-count":9,"title":["Efficacy and Safety of Eravacycline in Obese Patients: A Post Hoc Analysis of Pooled Data From the IGNITE1 and IGNITE4 Clinical Trials"],"prefix":"10.1093","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6268-0924","authenticated-orcid":false,"given":"Tomefa E","family":"Asempa","sequence":"first","affiliation":[{"name":"Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, Connecticut, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sergey","family":"Izmailyan","sequence":"additional","affiliation":[{"name":"Tetraphase Pharmaceuticals, Watertown, Massachusetts, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenneth","family":"Lawrence","sequence":"additional","affiliation":[{"name":"Tetraphase Pharmaceuticals, Watertown, Massachusetts, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4148-0165","authenticated-orcid":false,"given":"David P","family":"Nicolau","sequence":"additional","affiliation":[{"name":"Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, Connecticut, USA"},{"name":"Division of Infectious Diseases, Hartford Hospital, Hartford, Connecticut, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2020,11,13]]},"reference":[{"key":"2020122901400819900_CIT0001","doi-asserted-by":"crossref","first-page":"1081","DOI":"10.1592\/phco.27.8.1081","article-title":"Antimicrobial dosing considerations in obese adult patients","volume":"27","author":"Pai","year":"2007","journal-title":"Pharmacotherapy"},{"key":"2020122901400819900_CIT0002","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1080\/17425255.2018.1440287","article-title":"Obesity and drug pharmacology: a review of the influence of obesity on pharmacokinetic and pharmacodynamic parameters","volume":"14","author":"Smit","year":"2018","journal-title":"Expert Opin Drug Metab Toxicol"},{"key":"2020122901400819900_CIT0003","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1089\/sur.2016.261","article-title":"The surgical infection society revised guidelines on the management of intra-abdominal infection","volume":"18","author":"Mazuski","year":"2017","journal-title":"Surg Infect (Larchmt)"},{"key":"2020122901400819900_CIT0004","doi-asserted-by":"crossref","first-page":"112","DOI":"10.1086\/514505","article-title":"Antimicrobial dosing in obese patients","volume":"25","author":"Wurtz","year":"1997","journal-title":"Clin Infect Dis"},{"key":"2020122901400819900_CIT0005","first-page":"780","article-title":"The obesity epidemic: challenges, health initiatives, and implications for gastroenterologists","volume":"6","author":"Hurt","year":"2010","journal-title":"Gastroenterol Hepatol (N Y)"},{"key":"2020122901400819900_CIT0006","doi-asserted-by":"crossref","first-page":"161","DOI":"10.21037\/atm.2017.03.107","article-title":"Morbidity and mortality associated with obesity","volume":"5","author":"Abdelaal","year":"2017","journal-title":"Ann Transl Med"},{"key":"2020122901400819900_CIT0007","author":"Hales","year":"2017"},{"key":"2020122901400819900_CIT0008"},{"key":"2020122901400819900_CIT0009","volume-title":"Xerava (eravacycline) injection, for intravenous use. 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