{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T00:11:51Z","timestamp":1788480711869,"version":"build-2803163510"},"reference-count":35,"publisher":"American Society for Microbiology","issue":"1","license":[{"start":{"date-parts":[[2024,1,17]],"date-time":"2024-01-17T00:00:00Z","timestamp":1705449600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,1,17]],"date-time":"2024-01-17T00:00:00Z","timestamp":1705449600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/100017639","name":"Entasis Therapeutics","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100017639","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2024,1,17]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            Sulbactam-durlobactam is a \u03b2-lactam\/\u03b2-lactamase inhibitor combination developed to treat hospital-acquired and ventilator-associated bacterial pneumonia caused by\n            <jats:italic>Acinetobacter baumannii-calcoaceticus<\/jats:italic>\n            complex (ABC). Durlobactam is a diazabicyclooctane \u03b2-lactamase inhibitor with potent activity against Ambler classes A, C, and D serine \u03b2-lactamases and restores sulbactam activity against multidrug-resistant ABC. Studies were conducted to establish sulbactam-durlobactam antimicrobial susceptibility testing methods for both broth microdilution minimal inhibitory concentration (MIC) and disk diffusion tests as well as quality control (QC) ranges. To establish the MIC test method, combinations of sulbactam and durlobactam were evaluated using a panel of genetically characterized\n            <jats:italic>A. baumannii<\/jats:italic>\n            isolates which were categorized as predicted to be susceptible or resistant based on the spectrum of \u03b2-lactamase inhibition by durlobactam. MIC testing with doubling dilutions of sulbactam with a fixed concentration of 4 \u00b5g\/mL of durlobactam resulted in the greatest discrimination of the pre-defined susceptible and resistant strains. Similarly, the sulbactam\/durlobactam 10\/10 \u00b5g disk concentration showed the best discrimination as well as correlation with the MIC test.\n            <jats:italic>A. baumannii<\/jats:italic>\n            NCTC 13304 was selected for QC purposes because it assesses the activity of both sulbactam and durlobactam with clear endpoints. Multi-laboratory QC studies were conducted according to CLSI M23 Tier 2 criteria. A sulbactam-durlobactam broth MIC QC range of 0.5\/4\u20132\/4 \u00b5g\/mL and a zone diameter QC range of 24\u201330 mm were determined for\n            <jats:italic>A. baumannii<\/jats:italic>\n            NCTC 13304 and have been approved by CLSI. These studies will enable clinical laboratories to perform susceptibility tests with accurate and reproducible methods.\n          <\/jats:p>","DOI":"10.1128\/jcm.01228-23","type":"journal-article","created":{"date-parts":[[2023,12,14]],"date-time":"2023-12-14T14:01:21Z","timestamp":1702562481000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":9,"title":["Sulbactam-durlobactam susceptibility test method development and quality control ranges for MIC and disk diffusion tests"],"prefix":"10.1128","volume":"62","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-7827-794X","authenticated-orcid":true,"given":"Sarah M.","family":"McLeod","sequence":"first","affiliation":[{"name":"Entasis Therapeutics Inc. (an affiliate of Innoviva Specialty Therapeutics, Inc.), Waltham, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3946-8052","authenticated-orcid":false,"given":"Nicole M.","family":"Carter","sequence":"additional","affiliation":[{"name":"Entasis Therapeutics Inc. (an affiliate of Innoviva Specialty Therapeutics, Inc.), Waltham, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9769-9019","authenticated-orcid":false,"given":"Michael D.","family":"Huband","sequence":"additional","affiliation":[{"name":"JMI Labs, North Liberty, Iowa, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria M.","family":"Traczewski","sequence":"additional","affiliation":[{"name":"Clinical Microbiology Institute, Wilsonville, Oregon, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1285-2978","authenticated-orcid":true,"given":"Patricia A.","family":"Bradford","sequence":"additional","affiliation":[{"name":"Antimicrobial Development Specialists, LLC, Nyack, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7110-0493","authenticated-orcid":false,"given":"Alita A.","family":"Miller","sequence":"additional","affiliation":[{"name":"Entasis Therapeutics Inc. (an affiliate of Innoviva Specialty Therapeutics, Inc.), Waltham, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","unstructured":"Entasis Therapeutics Inc. 2023. XACDURO\u00ae (sulbactam for injection; durlobactam for injection) co-packaged for intravenous use. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/216974Orig1s000Correctedlbl.pdf. Retrieved 4 Nov 2023."},{"key":"e_1_3_3_3_2","first-page":"37","article-title":"Sulbactam: a beta-lactamase inhibitor","volume":"7","author":"Noguchi JK","year":"1988","unstructured":"Noguchi JK, Gill MA. 1988. Sulbactam: a beta-lactamase inhibitor. Clin Pharm 7:37\u201351.","journal-title":"Clin Pharm"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.04808-14"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1038\/nmicrobiol.2017.104"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkt275"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.3389\/fmicb.2015.00231"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1469-0691.2005.01265.x"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.6.1941-1947.2004"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cit017"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1469-0691.2011.03752.x"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dks468"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1086\/647952"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.24.1.31"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.45.6.1919-1922.2001"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.37.12.2578"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/0732-8893(89)90084-9"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.36.2.394"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01960-17"},{"key":"e_1_3_3_20_2","volume-title":"M07-A11 methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically","author":"CLSI","year":"2018","unstructured":"CLSI. 2018. 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