Universität zu Köln

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:	Creators Email ORCID ORCID Put Code Harris, P. N. A. UNSPECIFIED UNSPECIFIED UNSPECIFIED McNamara, J. F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lye, D. C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Davis, J. S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bernard, L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cheng, A. C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Doi, Y. UNSPECIFIED UNSPECIFIED UNSPECIFIED Fowler, V. G., Jr. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaye, K. S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Leibovici, L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lipman, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Llewelyn, M. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Munoz-Price, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Paul, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Peleg, A. Y. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rodriguez-Bano, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rogers, B. A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Seifert, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Thamlikitkul, V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Thwaites, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Tong, S. Y. C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Turnidge, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Utili, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Webb, S. A. R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Paterson, D. L. UNSPECIFIED UNSPECIFIED UNSPECIFIED
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:	Keywords Language STAPHYLOCOCCUS-AUREUS BACTEREMIA; RANDOMIZED CONTROLLED-TRIAL; CRITICALLY-ILL PATIENTS; FAILURE ASSESSMENT SCORE; ESCHERICHIA-COLI; PROSPECTIVE MULTICENTER; BACTERIAL-INFECTIONS; MORTALITY; CARE; DAPTOMYCIN Multiple languages Infectious Diseases; Microbiology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/22366