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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 87-91 |
| Number of pages | 5 |
| Journal | Clinical Infectious Diseases |
| Volume | 64 |
| Issue number | 1 |
| DOIs | |
| State | Published - 2017 |
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Keywords
- Clinical trials
- CMV
- Organ transplantation
- Stem cell transplantation
ASJC Scopus subject areas
- Microbiology (medical)
- Infectious Diseases
Cite this
Definitions of cytomegalovirus infection and disease in transplant patients for use in clinical trials. / Ljungman, Per; Boeckh, Michael; Hirsch, Hans H.; Josephson, Filip; Lundgren, Jens; Nichols, Garrett; Pikis, Andreas; Razonable, Raymund R; Miller, Veronica; Griffiths, Paul D.
In: Clinical Infectious Diseases, Vol. 64, No. 1, 2017, p. 87-91.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Definitions of cytomegalovirus infection and disease in transplant patients for use in clinical trials
AU - Ljungman, Per
AU - Boeckh, Michael
AU - Hirsch, Hans H.
AU - Josephson, Filip
AU - Lundgren, Jens
AU - Nichols, Garrett
AU - Pikis, Andreas
AU - Razonable, Raymund R
AU - Miller, Veronica
AU - Griffiths, Paul D.
PY - 2017
Y1 - 2017
N2 - 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.
AB - 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.
KW - Clinical trials
KW - CMV
KW - Organ transplantation
KW - Stem cell transplantation
UR - http://www.scopus.com/inward/record.url?scp=85015219866&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85015219866&partnerID=8YFLogxK
U2 - 10.1093/cid/ciw668
DO - 10.1093/cid/ciw668
M3 - Article
C2 - 27682069
AN - SCOPUS:85015219866
VL - 64
SP - 87
EP - 91
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
SN - 1058-4838
IS - 1
ER -