Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials

Per Ljungman; Michael Boeckh; Hans H Hirsch; Filip Josephson; Jens Lundgren; Garrett Nichols; Andreas Pikis; Raymund R Razonable; Veronica Miller; Paul D Griffiths; Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum

doi:10.1093/cid/ciw668

Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials

Per Ljungman, Michael Boeckh, Hans H Hirsch, Filip Josephson, Jens Lundgren, Garrett Nichols, Andreas Pikis, Raymund R Razonable, Veronica Miller, Paul D Griffiths, Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum

Institut for Klinisk Medicin

325 Citationer (Scopus)

Abstract

Cytomegalovirus (CMV) infection and disease are important causes of morbidity and mortality in transplant recipients. For the purpose of developing consistent reporting of CMV outcomes in clinical trials, definitions of CMV infection and disease were developed and most recently published in 2002. Since then, there have been major developments in its diagnosis and management. Therefore, the CMV Drug Development Forum consisting of scientists, clinicians, regulators, and industry representatives has produced an updated version incorporating recent knowledge with the aim to support clinical research and drug development. The main changes compared to previous definitions are the introduction of a "probable disease" category and to incorporate quantitative nucleic acid testing in some end-organ disease categories. As the field evolves, the need for updates of these definitions is clear, and collaborative efforts between scientists, regulators, and industry can provide a platform for this work.

Originalsprog	Engelsk
Tidsskrift	Clinical Infectious Diseases
Vol/bind	64
Udgave nummer	1
Sider (fra-til)	87-91
Antal sider	5
ISSN	1058-4838
DOI	https://doi.org/10.1093/cid/ciw668
Status	Udgivet - 1 jan. 2017

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10.1093/cid/ciw668

ciw668.pdfForlagets udgivne version, 185 KB

https://academic.oup.com/cid/article-pdf/64/1/87/8485320/ciw668.pdf

Citationsformater

Ljungman, P., Boeckh, M., Hirsch, H. H., Josephson, F., Lundgren, J., Nichols, G., Pikis, A., Razonable, R. R., Miller, V., Griffiths, P. D., & Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum (2017). Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials. Clinical Infectious Diseases, 64(1), 87-91. https://doi.org/10.1093/cid/ciw668

Ljungman, P, Boeckh, M, Hirsch, HH, Josephson, F, Lundgren, J, Nichols, G, Pikis, A, Razonable, RR, Miller, V, Griffiths, PD & Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum 2017, 'Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials', Clinical Infectious Diseases, bind 64, nr. 1, s. 87-91. https://doi.org/10.1093/cid/ciw668

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Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials

Abstract

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