{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T17:52:59Z","timestamp":1760205179192,"version":"3.41.2"},"reference-count":24,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2022,5,9]],"date-time":"2022-05-09T00:00:00Z","timestamp":1652054400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,7,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The prospective identification of patients at high risk for hospital-acquired\/ventilator-associated bacterial pneumonia may improve clinical trial feasibility and foster antibacterial development. In a prior study conducted in the United States, clinical criteria were used to prospectively identify these patients; however, these criteria have not been applied in a European population.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Adults considered high risk for pneumonia (treatment with ventilation or high levels of supplemental oxygen) in the intensive care units of 7 European hospitals were prospectively enrolled from June 12 to December 27, 2017. We estimated the proportion of high-risk patients developing pneumonia according to US Food and Drug Administration guidance and a subset potentially eligible for antibacterial trial enrollment. We compared patient characteristics, treatment exposures, and pneumonia incidence in a European cohort and a previously described US cohort.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of 888 high-risk patients, 211\/888 (24%) were treated for possible pneumonia, and 150\/888 (17%) met the Food and Drug Administration definition for hospital-acquired\/ventilator-associated bacterial pneumonia. A higher proportion of European patients treated for possible pneumonia met the pneumonia definition (150\/211 [71%] vs 537\/1464 [37%]; P\u2009&amp;lt;\u2009.001). Among patients developing pneumonia, a higher proportion of European patients met antibacterial trial eligibility criteria (124\/150 [83%] vs 371\/537 [69%]; P\u2009&amp;lt;\u2009.001).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Clinical criteria prospectively identified high-risk patients with high rates of pneumonia in the European cohort. Despite higher rates of established risk factors and incident pneumonia, European patients were significantly less likely to receive antibiotics for possible pneumonia than US patients. Different treatment practices may contribute to lower rates of antibacterial trial enrollment in the United States.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ofid\/ofac231","type":"journal-article","created":{"date-parts":[[2022,5,9]],"date-time":"2022-05-09T03:25:38Z","timestamp":1652066738000},"source":"Crossref","is-referenced-by-count":1,"title":["PROPHETIC EU: Prospective Identification of Pneumonia in Hospitalized Patients in the Intensive Care Unit in European and United States Cohorts"],"prefix":"10.1093","volume":"9","author":[{"given":"Stephen P","family":"Bergin","sequence":"first","affiliation":[{"name":"Duke University , Durham, North Carolina , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4229-2729","authenticated-orcid":false,"given":"Sara B","family":"Calvert","sequence":"additional","affiliation":[{"name":"Clinical Trials Transformation Initiative , Durham, North Carolina , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Farley","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration, Center for Drug Evaluation and Research , Silver Spring, Maryland , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jie-Lena","family":"Sun","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute , Durham, North Carolina , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen","family":"Chiswell","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute , Durham, North Carolina , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Willem","family":"Dieperink","sequence":"additional","affiliation":[{"name":"University Medical Center Groningen , Groningen , the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jan","family":"Kluytmans","sequence":"additional","affiliation":[{"name":"Amphia Hospital , Breda , the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juan Carlos","family":"Lopez-Delgado","sequence":"additional","affiliation":[{"name":"Bellvitge University Hospital , Barcelona , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rafael","family":"Leon-Lopez","sequence":"additional","affiliation":[{"name":"Reina Sof\u00eda University Hospital\/University of C\u00f3rdoba , C\u00f3rdoba , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7328-4898","authenticated-orcid":false,"given":"Marcus J","family":"Zervos","sequence":"additional","affiliation":[{"name":"Henry Ford Health System , Detroit, Michigan , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marin H","family":"Kollef","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine , St Louis, Missouri , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Sims","sequence":"additional","affiliation":[{"name":"Beaumont Health System , Royal Oak, Michigan , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Badih A","family":"Kabchi","sequence":"additional","affiliation":[{"name":"East Carolina University , Greenville, North Carolina , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Rubin","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration, Center for Drug Evaluation and Research , Silver Spring, Maryland , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonas","family":"Santiago","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration, Center for Drug Evaluation and Research , Silver Spring, Maryland , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mukil","family":"Natarajan","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration, Center for Drug Evaluation and Research , Silver Spring, Maryland , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pamela","family":"Tenaerts","sequence":"additional","affiliation":[{"name":"Clinical Trials Transformation Initiative , Durham, North Carolina , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vance G","family":"Fowler","sequence":"additional","affiliation":[{"name":"Duke University , Durham, North Carolina , USA"},{"name":"Duke Clinical Research Institute , Durham, North Carolina , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas L","family":"Holland","sequence":"additional","affiliation":[{"name":"Duke University , Durham, North Carolina , USA"},{"name":"Duke Clinical Research Institute , Durham, North Carolina , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc J","family":"Bonten","sequence":"additional","affiliation":[{"name":"University Medical Center Utrecht , Utrecht , the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sebastiaan J","family":"Hullegie","sequence":"additional","affiliation":[{"name":"University Medical Center Utrecht , Utrecht , the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2022,5,9]]},"reference":[{"key":"2022073010011316100_ofac231-B1","doi-asserted-by":"crossref","first-page":"423","DOI":"10.1016\/j.ajic.2019.08.023","article-title":"International Nosocomial Infection Control Consortium (INICC) report, data summary of 45 countries for 2012\u20132017: device-associated module","volume":"48","author":"Rosenthal","year":"2020","journal-title":"Am J Infect 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