{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T03:12:40Z","timestamp":1793502760264,"version":"4.5.0"},"reference-count":45,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2018,12,18]],"date-time":"2018-12-18T00:00:00Z","timestamp":1545091200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Tetraphase Pharmaceuticals Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,8,30]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Increasing antimicrobial resistance among pathogens that cause complicated intraabdominal infections (cIAIs) supports the development of new antimicrobials. Eravacycline, a novel member of the fluorocycline family, is active against multidrug-resistant bacteria including extended-spectrum \u03b2-lactamase (ESBL) and carbapenem-resistant Enterobacteriaceae.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>IGNITE4 was a prospective, randomized, double-blind trial. Hospitalized patients with cIAI received either eravacycline 1 mg\/kg every 12 hours or meropenem 1 g every 8 hours intravenously for 4\u201314 days. The primary objective was to demonstrate statistical noninferiority (NI) in clinical cure rates at the test-of-cure visit (25\u201331 days from start of therapy) in the microbiological intent-to-treat population using a NI margin of 12.5%. Microbiological outcomes and safety were also evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Eravacycline was noninferior to meropenem in the primary endpoint (177\/195 [90.8%] vs 187\/205 [91.2%]; difference, \u20130.5%; 95% confidence interval [CI], \u20136.3 to 5.3), exceeding the prespecified margin. Secondary endpoints included clinical cure rates in the modified ITT population (231\/250 [92.4%] vs 228\/249 [91.6%]; difference, 0.8; 95% CI, \u20134.1, 5.8) and the clinically evaluable population (218\/225 [96.9%] vs 222\/231 [96.1%]; (difference, 0.8; 95% CI \u20132.9, 4.5). In patients with ESBL-producing Enterobacteriaceae, clinical cure rates were 87.5% (14\/16) and 84.6% (11\/13) in the eravacycline and meropenem groups, respectively. Eravacycline had relatively low rates of adverse events for a drug of this class, with less than 5%, 4%, and 3% of patients experiencing nausea, vomiting, and diarrhea, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Treatment with eravacycline was noninferior to meropenem in adult patients with cIAI, including infections caused by resistant pathogens.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registration<\/jats:title>\n                    <jats:p>NCT01844856.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciy1029","type":"journal-article","created":{"date-parts":[[2018,12,12]],"date-time":"2018-12-12T15:11:47Z","timestamp":1544627507000},"page":"921-929","source":"Crossref","is-referenced-by-count":212,"title":["IGNITE4: Results of a Phase 3, Randomized, Multicenter, Prospective Trial of Eravacycline vs Meropenem in the Treatment of Complicated Intraabdominal Infections"],"prefix":"10.1093","volume":"69","author":[{"given":"Joseph S","family":"Solomkin","sequence":"first","affiliation":[{"name":"Department of Surgery, University of Cincinnati College of Medicine, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janis","family":"Gardovskis","sequence":"additional","affiliation":[{"name":"Department of Surgery, Riga Stradins University, Latvia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth","family":"Lawrence","sequence":"additional","affiliation":[{"name":"Tetraphase Pharmaceuticals, Watertown, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Montravers","sequence":"additional","affiliation":[{"name":"D\u00e9partement d\u2019Anesth\u00e9sie-R\u00e9animation, CHU Bichat Claude Bernard"},{"name":"Universit\u00e9 Paris Diderot, PRESS Sorbonne Cit\u00e9, Paris, France"},{"name":"Institut National de la Sant\u00e9 et de la Recherche M\u00e9dicale (INSERM) UMR, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angie","family":"Sway","sequence":"additional","affiliation":[{"name":"World Surgical Infection Society, Cincinnati, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Evans","sequence":"additional","affiliation":[{"name":"Department of Surgery, Ohio State University School of Medicine, Columbus"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Larry","family":"Tsai","sequence":"additional","affiliation":[{"name":"Tetraphase Pharmaceuticals, Watertown, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2018,12,18]]},"reference":[{"key":"2019091011565382300_CIT0001","year":"2013"},{"key":"2019091011565382300_CIT0002","year":"2018"},{"key":"2019091011565382300_CIT0003","year":"2018"},{"key":"2019091011565382300_CIT0004","unstructured":"Antimicrobial resistance. 2018. 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