Journal article
Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition
PNA Harris, JF McNamara, DL Paterson, DC Lye, JS Davis, SYC Tong, L Bernard, AC Cheng, Y Doi, VG Fowler, KS Kaye, L Leibovici, J Lipman, MJ Llewelyn, S Munoz-Price, M Paul, AY Peleg, BA Rogers, J Rodríguez-Baño, H Seifert Show all
Clinical Microbiology and Infection | ELSEVIER SCI LTD | Published : 2017
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-negativ..
View full abstractGrants
Awarded by Australia-China Council
Funding Acknowledgements
No funding source was required for the preparation of this manuscript. PH is supported by an Australian Postgraduate Award from the University of Queensland. VGF was supported by R01AI068804 from National Institutes of Health. KSK is supported by the National Institute of Allergy and Infectious Diseases (NIAID), DMID Protocol no. 10-0065 and R01AI119446. ACC and AYP were supported by an Australian National Health and Medical Research Council Career Development Fellowship. HS receives funding from the German Centre for Infection Research (DZIF), Germany. JRB receives funding for research from Ministerio de Economia y Competitividad, Instituto de Salud Carlos III-co-financed by European Development Regional Fund 'A way to achieve Europe' ERDF, Spanish Network for the Research in Infectious Diseases (REIPI RD12/0015). JRB and MP receive funding from Innovatives Medicine Initiative (IMI), European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies (COMBACTE, COMBACTE-CARE and COMBACTE-MAGNET projects, grant agreements 1155223, 115620 and 115737). RU and MP are supported by the European Union 7th Framework Programme (Project 'AIDA'). SYCT is supported by an NHMRC Career Development Fellowship 1065736. JT received funding from NHMRC (Project Grant ID 1044941).