Harris, P. N. A., McNamara, J. F., Lye, D. C., Davis, J. S., Bernard, L., Cheng, A. C., Doi, Y., Fowler, V. G., Jr., Kaye, K. S., Leibovici, L., Lipman, J., Llewelyn, M. J., Munoz-Price, S., Paul, M., Peleg, A. Y., Rodriguez-Bano, J., Rogers, B. A., Seifert, H., Thamlikitkul, V., Thwaites, G., Tong, S. Y. C., Turnidge, J., Utili, R., Webb, S. A. R. and Paterson, D. L. (2017). Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition. Clin. Microbiol. Infect., 23 (8). S. 533 - 542. OXFORD: ELSEVIER SCI LTD. ISSN 1469-0691

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Abstract

Objectives: To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI). 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. 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. 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. (C) 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Harris, P. N. A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
McNamara, J. F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lye, D. C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Davis, J. S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bernard, L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cheng, A. C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doi, Y.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fowler, V. G., Jr.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kaye, K. S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Leibovici, L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lipman, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Llewelyn, M. J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Munoz-Price, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Paul, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Peleg, A. Y.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rodriguez-Bano, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rogers, B. A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seifert, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thamlikitkul, V.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thwaites, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tong, S. Y. C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Turnidge, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Utili, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Webb, S. A. R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Paterson, D. L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-223662
DOI: 10.1016/j.cmi.2016.10.023
Journal or Publication Title: Clin. Microbiol. Infect.
Volume: 23
Number: 8
Page Range: S. 533 - 542
Date: 2017
Publisher: ELSEVIER SCI LTD
Place of Publication: OXFORD
ISSN: 1469-0691
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
STAPHYLOCOCCUS-AUREUS BACTEREMIA; RANDOMIZED CONTROLLED-TRIAL; CRITICALLY-ILL PATIENTS; FAILURE ASSESSMENT SCORE; ESCHERICHIA-COLI; PROSPECTIVE MULTICENTER; BACTERIAL-INFECTIONS; MORTALITY; CARE; DAPTOMYCINMultiple languages
Infectious Diseases; MicrobiologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/22366

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