{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T02:02:48Z","timestamp":1785895368461,"version":"3.56.0"},"reference-count":69,"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\/501100001794","name":"University of Queensland","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001794","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:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Increasing antimicrobial resistance (AMR) is a global public health concern. Rapid and effective evaluation of interventions for antibiotic-resistant organisms is needed. Randomized controlled trials (RCTs) provide the strongest evidence of causal effects of an intervention. However, conducting antibiotic RCTs has many challenges. We explored antibiotic RCT designs and methodology, to gain an understanding of current approaches and potential solutions for future antibiotic trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a targeted literature review for antibiotic RCTs from 2013 to 2022 published in high impact medical and subspecialty journals. Data extracted included study demographics, characteristics, and trial design features.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The search identified 193 trials. The majority were supported by non-industry sources (72.0%), multicenter (90.7%), 2-arm trials (88.6%) with a parallel design (98.4%) and enrolled adults only (68.4%). Only 52 trials (26.9%) involved sites in low- or middle-income countries (LMICs). The median sample size was 500 (interquartile range [IQR] 253\u2013777) with a significantly larger sample size in industry supported trials. However, non-industry supported trials were of longer duration than industry supported trials (median 36 vs 18 months). All trials utilized a frequentist method.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The most common trials were multicenter, 2-arm trials with parallel traditional RCT designs. Although platform trials are currently ongoing, traditional designs were overwhelmingly used. Study involvement in countries with the highest AMR burden were grossly under-represented. Innovative trial methodologies\u2014such as adaptive, platform, and pathogen-directed designs\u2014should be prioritized to improve efficiency, flexibility, and relevance. Future trials must integrate real-world data, harmonize regulatory requirements, and support equitable global participation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciag017","type":"journal-article","created":{"date-parts":[[2026,1,10]],"date-time":"2026-01-10T12:37:47Z","timestamp":1768048667000},"page":"S126-S137","source":"Crossref","is-referenced-by-count":1,"title":["Antibiotic Clinical Trials: A Review of the Past, Present Challenges, and Potential Solutions"],"prefix":"10.1093","volume":"82","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2427-6082","authenticated-orcid":false,"given":"Melissa J","family":"Hardy","sequence":"first","affiliation":[{"name":"University of Queensland Centre for Clinical Research Faculty of Medicine, , Brisbane, Queensland ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2895-0345","authenticated-orcid":false,"given":"Patrick N A","family":"Harris","sequence":"additional","affiliation":[{"name":"University of Queensland Centre for Clinical Research Faculty of Medicine, , Brisbane, Queensland ,","place":["Australia"]},{"name":"Central Microbiology Laboratory, Pathology Queensland , Brisbane, Queensland ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yin","family":"Mo","sequence":"additional","affiliation":[{"name":"ADVANCE-ID, Saw Swee Hock School of Public Health, National University of Singapore , Singapore ,","place":["Singapore"]},{"name":"Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford , Oxford ,","place":["United Kingdom"]},{"name":"Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University , Bangkok ,","place":["Thailand"]},{"name":"Division of Infectious Diseases, University Medicine Cluster, National University Hospital , Singapore 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Intensive Care, Royal North Shore Hospital , Sydney, NSW ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2370-2438","authenticated-orcid":false,"given":"Trisha N","family":"Peel","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, The Alfred , Melbourne, Victoria ,","place":["Australia"]},{"name":"School of Translational Medicine, Monash University , Melbourne, Victoria ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David L","family":"Paterson","sequence":"additional","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 Loo Lin School of Medicine, National University of Singapore , Singapore 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