{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T23:35:52Z","timestamp":1792798552280,"version":"4.5.0"},"reference-count":26,"publisher":"American Society for Microbiology","issue":"7","license":[{"start":{"date-parts":[[2024,7,9]],"date-time":"2024-07-09T00:00:00Z","timestamp":1720483200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,7,9]],"date-time":"2024-07-09T00:00:00Z","timestamp":1720483200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"name":"HHS | Biomedical Advanced Research and Development Authority","award":["HHSO100201900007C"],"award-info":[{"award-number":["HHSO100201900007C"]}],"id":[{"id":"https:\/\/ror.org\/029y69023","id-type":"ROR","asserted-by":"crossref"}]},{"name":"HHS | Biomedical Advanced Research and Development Authority","award":["75A50122C00080"],"award-info":[{"award-number":["75A50122C00080"]}],"id":[{"id":"https:\/\/ror.org\/029y69023","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Venatorx Pharmaceuticals, Inc.","id":[{"id":"https:\/\/ror.org\/02s3j1d69","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Global Antibiotic Research and Development Partnership (GARDP) Foundation","id":[{"id":"https:\/\/ror.org\/0284j4180","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Everest Medicines"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2024,7,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      CERTAIN-1 was a Phase 3, double-blind, randomized, parallel group study of the efficacy and safety of cefepime-taniborbactam versus meropenem in the treatment of adults with complicated urinary tract infection (cUTI), including acute pyelonephritis. We determined susceptibility of Enterobacterales and\n                      <jats:italic>Pseudomonas aeruginosa<\/jats:italic>\n                      baseline pathogens to cefepime-taniborbactam and comparators and characterized \u03b2-lactam resistance mechanisms. Microbiologic response and clinical response were assessed in patient subsets defined by baseline pathogens that were of cefepime-, multidrug-, or carbapenem-resistant phenotype or that carried \u03b2-lactamase genes. Among Enterobacterales baseline pathogens, 26.8%, 4.1%, and 3.0% carried genes for extended-spectrum \u03b2-lactamases (ESBLs), AmpC, and carbapenemases, respectively. Within each treatment group, while composite success rates at Test of Cure in resistant subsets by pathogen species were similar to those by pathogen overall, composite success rates in meropenem patients were numerically lower for cefepime-resistant\n                      <jats:italic>Escherichia coli<\/jats:italic>\n                      (9\/19; 47.4%) and ESBL\n                      <jats:italic>E. coli<\/jats:italic>\n                      (13\/25; 52.0%) compared with\n                      <jats:italic>E. coli<\/jats:italic>\n                      overall (62\/100; 62.0%). Cefepime-taniborbactam achieved composite success in 7\/8 (87.5%) patients with carbapenem-resistant Enterobacterales and 8\/9 (88.9%) patients with Enterobacterales with a carbapenemase gene (5 OXA-48-group; 2 KPC-3; 2 NDM-1). Cefepime-taniborbactam also achieved composite success in 8\/16 (50.0%) patients and clinical success in 13\/16 (81.3%) patients with\n                      <jats:italic>P. aeruginosa<\/jats:italic>\n                      ; corresponding rates were 4\/7 (57.1%) and 6\/7 (85.7%) for meropenem. Cefepime-taniborbactam demonstrated efficacy in adult cUTI patients with cefepime-, multidrug-, and carbapenem-resistant pathogens including pathogens with ESBL, AmpC, and carbapenemase genes.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CLINICAL TRIALS<\/jats:title>\n                    <jats:p>\n                      This study is registered with\n                      <jats:related-object xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" content-type=\"pre-results\" document-id=\"NCT03840148\" document-id-type=\"clinical-trial-number\" source-id=\"http:\/\/clinicaltrials.gov\/\" source-id-type=\"registry-nameov\" source-type=\"clinical-trials-registry\" xlink:href=\"https:\/\/clinicaltrials.gov\/show\/NCT03840148\">\n                        <jats:ext-link ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\/\" xlink:type=\"simple\">ClinicalTrials.gov<\/jats:ext-link>\n                        as\n                        <jats:ext-link ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT03840148\" xlink:type=\"simple\">NCT03840148<\/jats:ext-link>\n                      <\/jats:related-object>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1128\/aac.00236-24","type":"journal-article","created":{"date-parts":[[2024,5,23]],"date-time":"2024-05-23T09:00:59Z","timestamp":1716454859000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":27,"title":["Patient outcomes by baseline pathogen resistance phenotype and genotype in CERTAIN-1, a Phase 3 study of cefepime-taniborbactam versus meropenem in adults with complicated urinary tract infection"],"prefix":"10.1128","volume":"68","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7827-7227","authenticated-orcid":true,"given":"Greg","family":"Moeck","sequence":"first","affiliation":[{"name":"Venatorx Pharmaceuticals, Inc., Malvern, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leanne B.","family":"Gasink","sequence":"additional","affiliation":[{"name":"LBG Consulting, LLC, Saint Davids, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8648-1137","authenticated-orcid":false,"given":"Rodrigo E.","family":"Mendes","sequence":"additional","affiliation":[{"name":"JMI Laboratories, North Liberty, Iowa, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1244-6830","authenticated-orcid":false,"given":"Leah N.","family":"Woosley","sequence":"additional","affiliation":[{"name":"JMI Laboratories, North Liberty, Iowa, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0397-7146","authenticated-orcid":false,"given":"MaryBeth","family":"Dorr","sequence":"additional","affiliation":[{"name":"Venatorx Pharmaceuticals, Inc., Malvern, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-1561-952X","authenticated-orcid":false,"given":"Hongzi","family":"Chen","sequence":"additional","affiliation":[{"name":"Venatorx Pharmaceuticals, Inc., Malvern, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2909-0797","authenticated-orcid":false,"given":"Florian M.","family":"Wagenlehner","sequence":"additional","affiliation":[{"name":"Justus Liebig University, Giessen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6347-5247","authenticated-orcid":true,"given":"Tim","family":"Henkel","sequence":"additional","affiliation":[{"name":"Venatorx Pharmaceuticals, Inc., Malvern, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5906-2818","authenticated-orcid":false,"given":"Paul C.","family":"McGovern","sequence":"additional","affiliation":[{"name":"Venatorx Pharmaceuticals, Inc., Malvern, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","volume-title":"Prioritization of pathogens to guide discovery, research and development of new antibiotics for drug-resistant bacterial infections,including tuberculosis","author":"World Health Organization","year":"2017","unstructured":"World Health Organization. 2017. Prioritization of pathogens to guide discovery, research and development of new antibiotics for drug-resistant bacterial infections,including tuberculosis. World Health Organization (WHO), Geneva."},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofac492.716"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1080\/22221751.2022.2048972"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1128\/aac.01406-22"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2022.27.50.2200926"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciad428"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.9b01518"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01963-19"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/aac.02161-21"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1093\/jacamr\/dlab197"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1128\/aac.01281-22"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2304748"},{"key":"e_1_3_3_15_2","volume-title":"Performance standards for antimicrobial susceptibility testing","year":"2019","unstructured":"CLSI supplement M100. 2019. 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Time to change the complicated urinary tract infection primary endpoint? The problem and a potential solution. In ESCMID\/ASM joint conference on drug development. European Society for Clinical Microbiology and Infectious Diseases (ESCMID)\/American Society for Microbiology, Dublin, Ireland."},{"key":"e_1_3_3_29_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciy1121"}],"container-title":["Antimicrobial Agents and Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/aac.00236-24","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/aac.00236-24","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,9]],"date-time":"2024-07-09T09:06:02Z","timestamp":1720515962000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/aac.00236-24"}},"subtitle":[],"editor":[{"given":"Helen","family":"Boucher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2024,7,9]]},"references-count":26,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2024,7,9]]}},"alternative-id":["10.1128\/aac.00236-24"],"URL":"https:\/\/doi.org\/10.1128\/aac.00236-24","relation":{},"ISSN":["0066-4804","1098-6596"],"issn-type":[{"value":"0066-4804","type":"print"},{"value":"1098-6596","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,9]]},"assertion":[{"value":"2024-02-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-25","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-05-23","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00236-24"}}