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

Department of Clinical Medicine

325 Citations (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.

Original language	English
Journal	Clinical Infectious Diseases
Volume	64
Issue number	1
Pages (from-to)	87-91
Number of pages	5
ISSN	1058-4838
DOIs	https://doi.org/10.1093/cid/ciw668
Publication status	Published - 1 Jan 2017

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Journal Article

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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, vol. 64, no. 1, pp. 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

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