{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T08:07:22Z","timestamp":1780387642624,"version":"3.54.1"},"reference-count":55,"publisher":"Oxford University Press (OUP)","issue":"Supplement_5","license":[{"start":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T00:00:00Z","timestamp":1780358400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100019590","name":"CARB-X","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100019590","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002347","name":"Federal Ministry of Education and Research","doi-asserted-by":"publisher","award":["03LW0314"],"award-info":[{"award-number":["03LW0314"]}],"id":[{"id":"10.13039\/501100002347","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,6,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Randomized controlled trials for the regulatory approval of antibacterial agents almost always use a noninferiority design. Indeed, this should always be the default option when clinical development of new antibacterial agents is being planned. However, a superiority design may need to be considered for \u201cnontraditional\u201d antibacterial agents that are added to standard of care therapy. Therefore, it is necessary to consider how superiority trials might best be designed. Based on Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) antibacterial development discussions, we outline some key considerations for evaluable study populations, trial design, endpoints, and regulatory liaison in the context of superiority trials for new antibacterial agents.<\/jats:p>","DOI":"10.1093\/cid\/ciag207","type":"journal-article","created":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T11:32:24Z","timestamp":1774870344000},"page":"S138-S146","source":"Crossref","is-referenced-by-count":0,"title":["Considerations in Designing Clinical Trials of Novel Antibacterial Agents Using a Superiority Design"],"prefix":"10.1093","volume":"82","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2079-4437","authenticated-orcid":false,"given":"David L","family":"Paterson","sequence":"first","affiliation":[{"name":"ADVANCE-ID, Saw Swee Hock School of Public Health, National University of Singapore , Singapore ,","place":["Singapore"]},{"name":"Infectious Diseases Translational Research Programme, Yong Lee Lim School of Medicine, National University of Singapore , Singapore ,","place":["Singapore"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Melnick","sequence":"additional","affiliation":[{"name":"D&K Pharma Consulting , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron","family":"Dane","sequence":"additional","affiliation":[{"name":"DaneStat Consulting Ltd , Macclesfield ,","place":["United Kingdom"]},{"name":"University of Liverpool , Liverpool ,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Goldberger","sequence":"additional","affiliation":[{"name":"Independent Consultant, Potomac, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Schramm","sequence":"additional","affiliation":[{"name":"Federal Institute for Drugs and Medical Devices (Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte) , Bonn ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-1524-9004","authenticated-orcid":false,"given":"Susan S","family":"Huang","sequence":"additional","affiliation":[{"name":"University of California Irvine School of Medicine , Irvine, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nel","family":"Moore","sequence":"additional","affiliation":[{"name":"Independent Consultant, Freshwater East, Wales ,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2427-6082","authenticated-orcid":false,"given":"Melissa J","family":"Hardy","sequence":"additional","affiliation":[{"name":"Centre for Clinical Research, University of Queensland , Brisbane ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Su","family":"Chiang","sequence":"additional","affiliation":[{"name":"CARB-X, Boston University , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Uria-Nickelsen","sequence":"additional","affiliation":[{"name":"CARB-X, Boston University , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin M","family":"Duffy","sequence":"additional","affiliation":[{"name":"Gates Foundation , Seattle, Washington ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,6,2]]},"reference":[{"key":"2026060203213375600_ciag207-B1","author":"Legal Information Institute"},{"key":"2026060203213375600_ciag207-B2","doi-asserted-by":"crossref","first-page":"363","DOI":"10.7326\/M16-0291","article-title":"Progress in the fight against multidrug-resistant bacteria? 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