Ljungman, P;
Boeckh, M;
Hirsch, HH;
Josephson, F;
Lundgren, J;
Nichols, G;
Pikis, A;
... Griffiths, PD; + view all
(2017)
Definitions of cytomegalovirus infection and disease in transplant patients for use in clinical trials.
Clinical Infectious Diseases
, 64
(1)
pp. 87-91.
10.1093/cid/ciw668.
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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 aimto 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.
| Type: | Article |
|---|---|
| Title: | Definitions of cytomegalovirus infection and disease in transplant patients for use in clinical trials |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1093/cid/ciw668 |
| Publisher version: | http://doi.org/10.1093/cid/ciw668 |
| Language: | English |
| Additional information: | This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. |
| Keywords: | CMV, stem cell transplantation, organ transplantation, clinical trials |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Infection and Immunity |
| URI: | https://discovery.ucl.ac.uk/id/eprint/1546890 |
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