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Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition.

Identifieur interne : 000753 ( PubMed/Curation ); précédent : 000752; suivant : 000754

Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition.

Auteurs : P N A. Harris [Australie] ; J F Mcnamara [Australie] ; D C Lye [Singapour] ; J S Davis [Australie] ; L. Bernard [France] ; A C Cheng [Australie] ; Y. Doi [États-Unis] ; V G Fowler [États-Unis] ; K S Kaye [États-Unis] ; L. Leibovici [Israël] ; J. Lipman [Afrique du Sud] ; M J Llewelyn [Royaume-Uni] ; S. Munoz-Price [États-Unis] ; M. Paul [Israël] ; A Y Peleg [Australie] ; J. Rodríguez-Ba O [Espagne] ; B A Rogers [Australie] ; H. Seifert [Allemagne] ; V. Thamlikitkul [Thaïlande] ; G. Thwaites [Royaume-Uni] ; S Y C. Tong [Australie] ; J. Turnidge [Australie] ; R. Utili [Italie] ; S A R. Webb [Australie] ; D L Paterson [Australie]

Source :

RBID : pubmed:27810466

Abstract

To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI).

DOI: 10.1016/j.cmi.2016.10.023
PubMed: 27810466

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pubmed:27810466

Le document en format XML

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<name sortKey="Rodriguez Ba O, J" sort="Rodriguez Ba O, J" uniqKey="Rodriguez Ba O J" first="J" last="Rodríguez-Ba O">J. Rodríguez-Ba O</name>
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<nlm:affiliation>German Centre for Infection Research (DZIF), Braunschweig, Germany; Institute for Medical Microbiology, Immunology and Hygiene, University of Cologne, Cologne, Germany.</nlm:affiliation>
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<name sortKey="Thamlikitkul, V" sort="Thamlikitkul, V" uniqKey="Thamlikitkul V" first="V" last="Thamlikitkul">V. Thamlikitkul</name>
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<nlm:affiliation>Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.</nlm:affiliation>
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<nlm:affiliation>Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam; Nuffield Department of Medicine, University of Oxford, UK.</nlm:affiliation>
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<name sortKey="Tong, S Y C" sort="Tong, S Y C" uniqKey="Tong S" first="S Y C" last="Tong">S Y C. Tong</name>
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<nlm:affiliation>Internal Medicine, Second University of Naples, Italy.</nlm:affiliation>
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<nlm:affiliation>Royal Perth Hospital, and School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia.</nlm:affiliation>
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<name sortKey="Paterson, D L" sort="Paterson, D L" uniqKey="Paterson D" first="D L" last="Paterson">D L Paterson</name>
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<title xml:lang="en">Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition.</title>
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<name sortKey="Lye, D C" sort="Lye, D C" uniqKey="Lye D" first="D C" last="Lye">D C Lye</name>
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<nlm:affiliation>Institute of Infectious Disease and Epidemiology, Tan Tock Seng Hospital and Yong Loo Lin School of Medicine, Singapore.</nlm:affiliation>
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<nlm:affiliation>Global and Tropical Health Division, Menzies School of Health Research, Darwin, NT, Australia; Department of Infectious Diseases, John Hunter Hospital, Newcastle, NSW, Australia.</nlm:affiliation>
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<nlm:affiliation>Infectious Diseases Unit, Tours University Hospital, Tours, France.</nlm:affiliation>
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<nlm:affiliation>Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Vic., Australia; Department of Infectious Diseases, The Alfred Hospital and Central Clinical School, Monash University, Melbourne, Vic., Australia.</nlm:affiliation>
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<name sortKey="Doi, Y" sort="Doi, Y" uniqKey="Doi Y" first="Y" last="Doi">Y. Doi</name>
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<nlm:affiliation>Division of Infectious Diseases, University of Pittsburgh School of Medicine, PA, USA.</nlm:affiliation>
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<nlm:affiliation>Duke University Medical Center and Duke Clinical Research Institute, Durham, NC, USA.</nlm:affiliation>
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<nlm:affiliation>Wayne State University School of Medicine, Detroit Medical Center, Detroit, MI, USA.</nlm:affiliation>
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<nlm:affiliation>Burns, Trauma and Critical Care Research Centre, The University of Queensland, Brisbane, Qld, Australia; Department of Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Qld, Australia; The University of Witwatersrand, Johannesburg, South Africa.</nlm:affiliation>
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<name sortKey="Llewelyn, M J" sort="Llewelyn, M J" uniqKey="Llewelyn M" first="M J" last="Llewelyn">M J Llewelyn</name>
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<nlm:affiliation>Division of Medicine, Brighton and Sussex Medical School, Brighton, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
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<name sortKey="Munoz Price, S" sort="Munoz Price, S" uniqKey="Munoz Price S" first="S" last="Munoz-Price">S. Munoz-Price</name>
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<nlm:affiliation>Froedtert & Medical College of Wisconsin, Milwaukee, WI, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
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<name sortKey="Paul, M" sort="Paul, M" uniqKey="Paul M" first="M" last="Paul">M. Paul</name>
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<nlm:affiliation>Division of Infectious Diseases, Rambam Health Care Campus and The Ruth and Bruce Rappaport Faculty of Medicine, Technion, Israel Institute of Technology, Haifa, Israel.</nlm:affiliation>
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<wicri:regionArea>Department of Microbiology, Monash University, Melbourne, Vic., Australia; School of Clinical Sciences, Monash Medical Centre, Monash University, and Monash Infectious Diseases, Monash Health, Clayton, Vic.</wicri:regionArea>
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</affiliation>
</author>
<author>
<name sortKey="Thamlikitkul, V" sort="Thamlikitkul, V" uniqKey="Thamlikitkul V" first="V" last="Thamlikitkul">V. Thamlikitkul</name>
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<country xml:lang="fr">Thaïlande</country>
<wicri:regionArea>Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok</wicri:regionArea>
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<name sortKey="Thwaites, G" sort="Thwaites, G" uniqKey="Thwaites G" first="G" last="Thwaites">G. Thwaites</name>
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<nlm:affiliation>Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam; Nuffield Department of Medicine, University of Oxford, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam; Nuffield Department of Medicine, University of Oxford</wicri:regionArea>
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<name sortKey="Tong, S Y C" sort="Tong, S Y C" uniqKey="Tong S" first="S Y C" last="Tong">S Y C. Tong</name>
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<nlm:affiliation>Global and Tropical Health Division, Menzies School of Health Research, Darwin, NT, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Global and Tropical Health Division, Menzies School of Health Research, Darwin, NT</wicri:regionArea>
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<name sortKey="Turnidge, J" sort="Turnidge, J" uniqKey="Turnidge J" first="J" last="Turnidge">J. Turnidge</name>
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<name sortKey="Utili, R" sort="Utili, R" uniqKey="Utili R" first="R" last="Utili">R. Utili</name>
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<name sortKey="Webb, S A R" sort="Webb, S A R" uniqKey="Webb S" first="S A R" last="Webb">S A R. Webb</name>
<affiliation wicri:level="1">
<nlm:affiliation>Royal Perth Hospital, and School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Royal Perth Hospital, and School of Medicine and Pharmacology, University of Western Australia, Perth, WA</wicri:regionArea>
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<name sortKey="Paterson, D L" sort="Paterson, D L" uniqKey="Paterson D" first="D L" last="Paterson">D L Paterson</name>
<affiliation wicri:level="1">
<nlm:affiliation>University of Queensland, UQ Centre for Clinical Research, Brisbane, Qld, Australia; Wesley Medical Research, Wesley Hospital, Toowong, Qld, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>University of Queensland, UQ Centre for Clinical Research, Brisbane, Qld, Australia; Wesley Medical Research, Wesley Hospital, Toowong, Qld</wicri:regionArea>
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<title level="j">Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases</title>
<idno type="eISSN">1469-0691</idno>
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<date when="2017" type="published">2017</date>
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<div type="abstract" xml:lang="en">To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI).</div>
</front>
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<DateCreated>
<Year>2016</Year>
<Month>11</Month>
<Day>04</Day>
</DateCreated>
<DateRevised>
<Year>2017</Year>
<Month>08</Month>
<Day>06</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">1469-0691</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>23</Volume>
<Issue>8</Issue>
<PubDate>
<Year>2017</Year>
<Month>Aug</Month>
</PubDate>
</JournalIssue>
<Title>Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases</Title>
<ISOAbbreviation>Clin. Microbiol. Infect.</ISOAbbreviation>
</Journal>
<ArticleTitle>Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition.</ArticleTitle>
<Pagination>
<MedlinePgn>533-541</MedlinePgn>
</Pagination>
<ELocationID EIdType="pii" ValidYN="Y">S1198-743X(16)30512-2</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.cmi.2016.10.023</ELocationID>
<Abstract>
<AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI).</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Prospective studies, randomized trials or registered protocols comparing antibiotic therapies for BSI, published from 2005 to 2016, were reviewed. Consensus endpoints for BSI studies were defined using a modified Delphi process.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Different primary and secondary endpoints were defined for pilot (small-scale studies designed to evaluate protocol design, feasibility and implementation) and definitive trials (larger-scale studies designed to test hypotheses and influence clinical practice), as well as for Staphylococcus aureus and Gram-negative BSI. For pilot studies of S. aureus BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever, stable/improved Sequential Organ Failure Assessment (SOFA) score and clearance of blood cultures, with no microbiologically confirmed failure up to 90 days. For definitive S. aureus BSI studies, a primary outcome of success at 90 days was defined by survival and no microbiologically confirmed failure. For pilot studies of Gram-negative BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever and symptoms related to BSI source, stable or improved SOFA score and negative blood cultures. For definitive Gram-negative BSI studies, a primary outcome of survival at 90 days supported by a secondary outcome of success at day 7 (as previously defined) was agreed.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">These endpoints provide a framework to aid future trial design. Further work will be required to validate these endpoints with respect to patient-centred clinical outcomes.</AbstractText>
<CopyrightInformation>Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.</CopyrightInformation>
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<Author ValidYN="Y">
<LastName>Harris</LastName>
<ForeName>P N A</ForeName>
<Initials>PNA</Initials>
<AffiliationInfo>
<Affiliation>University of Queensland, UQ Centre for Clinical Research, Brisbane, Qld, Australia; Department of Microbiology, Pathology Queensland, Central Laboratory, Royal Brisbane & Women's Hospital, Brisbane, Qld, Australia. Electronic address: p.harris@uq.edu.au.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>McNamara</LastName>
<ForeName>J F</ForeName>
<Initials>JF</Initials>
<AffiliationInfo>
<Affiliation>University of Queensland, UQ Centre for Clinical Research, Brisbane, Qld, Australia; Department of Microbiology, Pathology Queensland, Central Laboratory, Royal Brisbane & Women's Hospital, Brisbane, Qld, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Lye</LastName>
<ForeName>D C</ForeName>
<Initials>DC</Initials>
<AffiliationInfo>
<Affiliation>Institute of Infectious Disease and Epidemiology, Tan Tock Seng Hospital and Yong Loo Lin School of Medicine, Singapore.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Davis</LastName>
<ForeName>J S</ForeName>
<Initials>JS</Initials>
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<Affiliation>Global and Tropical Health Division, Menzies School of Health Research, Darwin, NT, Australia; Department of Infectious Diseases, John Hunter Hospital, Newcastle, NSW, Australia.</Affiliation>
</AffiliationInfo>
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<LastName>Bernard</LastName>
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</AffiliationInfo>
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<LastName>Cheng</LastName>
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<Initials>AC</Initials>
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<Affiliation>Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Vic., Australia; Department of Infectious Diseases, The Alfred Hospital and Central Clinical School, Monash University, Melbourne, Vic., Australia.</Affiliation>
</AffiliationInfo>
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<ForeName>V G</ForeName>
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</AffiliationInfo>
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<Affiliation>Department of Medicine E, Beilinson Hospital, Rabin Medical Center, Petah-Tiqva, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.</Affiliation>
</AffiliationInfo>
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<Affiliation>Burns, Trauma and Critical Care Research Centre, The University of Queensland, Brisbane, Qld, Australia; Department of Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Qld, Australia; The University of Witwatersrand, Johannesburg, South Africa.</Affiliation>
</AffiliationInfo>
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</AffiliationInfo>
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<ForeName>S</ForeName>
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</AffiliationInfo>
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<LastName>Paul</LastName>
<ForeName>M</ForeName>
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</AffiliationInfo>
</Author>
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<LastName>Peleg</LastName>
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<AffiliationInfo>
<Affiliation>Department of Microbiology, Monash University, Melbourne, Vic., Australia; School of Clinical Sciences, Monash Medical Centre, Monash University, and Monash Infectious Diseases, Monash Health, Clayton, Vic., Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Rodríguez-Baño</LastName>
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<Affiliation>Unidad Clínica Intercentros de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospitales Universitarios Virgen Macarena y Virgen del Rocío-IBiS and Departamento de Medicina, Universidad de Sevilla, Seville, Spain.</Affiliation>
</AffiliationInfo>
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<LastName>Rogers</LastName>
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<Initials>BA</Initials>
<AffiliationInfo>
<Affiliation>School of Clinical Sciences, Monash Medical Centre, Monash University, and Monash Infectious Diseases, Monash Health, Clayton, Vic., Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Seifert</LastName>
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<AffiliationInfo>
<Affiliation>German Centre for Infection Research (DZIF), Braunschweig, Germany; Institute for Medical Microbiology, Immunology and Hygiene, University of Cologne, Cologne, Germany.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y">
<LastName>Thamlikitkul</LastName>
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<AffiliationInfo>
<Affiliation>Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.</Affiliation>
</AffiliationInfo>
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<LastName>Thwaites</LastName>
<ForeName>G</ForeName>
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<Affiliation>Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam; Nuffield Department of Medicine, University of Oxford, UK.</Affiliation>
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<LastName>Turnidge</LastName>
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<LastName>Utili</LastName>
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</AffiliationInfo>
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<LastName>Webb</LastName>
<ForeName>S A R</ForeName>
<Initials>SAR</Initials>
<AffiliationInfo>
<Affiliation>Royal Perth Hospital, and School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Paterson</LastName>
<ForeName>D L</ForeName>
<Initials>DL</Initials>
<AffiliationInfo>
<Affiliation>University of Queensland, UQ Centre for Clinical Research, Brisbane, Qld, Australia; Wesley Medical Research, Wesley Hospital, Toowong, Qld, Australia.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList>
<PublicationType UI="D016428">Journal Article</PublicationType>
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<Year>2016</Year>
<Month>11</Month>
<Day>01</Day>
</ArticleDate>
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<Country>England</Country>
<MedlineTA>Clin Microbiol Infect</MedlineTA>
<NlmUniqueID>9516420</NlmUniqueID>
<ISSNLinking>1198-743X</ISSNLinking>
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<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="N">Antibiotic therapy</Keyword>
<Keyword MajorTopicYN="N">Bacteraemia</Keyword>
<Keyword MajorTopicYN="N">Bacterial infections</Keyword>
<Keyword MajorTopicYN="N">Clinical trials</Keyword>
<Keyword MajorTopicYN="N">Treatment outcome</Keyword>
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<Month>08</Month>
<Day>02</Day>
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<Year>2016</Year>
<Month>10</Month>
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</PubMedPubDate>
<PubMedPubDate PubStatus="accepted">
<Year>2016</Year>
<Month>10</Month>
<Day>21</Day>
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