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

Research output: Contribution to journalArticle

160 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 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 languageEnglish (US)
Pages (from-to)87-91
Number of pages5
JournalClinical Infectious Diseases
Volume64
Issue number1
DOIs
StatePublished - 2017

Fingerprint

Cytomegalovirus Infections
Clinical Trials
Transplants
Cytomegalovirus
Industry
Pharmaceutical Preparations
Nucleic Acids
Morbidity
Mortality
Research

Keywords

  • Clinical trials
  • CMV
  • Organ transplantation
  • Stem cell transplantation

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Ljungman, P., Boeckh, M., Hirsch, H. H., Josephson, F., Lundgren, J., Nichols, G., ... Griffiths, P. D. (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

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 journalArticle

Ljungman, P, Boeckh, M, Hirsch, HH, Josephson, F, Lundgren, J, Nichols, G, Pikis, A, Razonable, RR, Miller, V & Griffiths, PD 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
Ljungman, Per ; Boeckh, Michael ; Hirsch, Hans H. ; Josephson, Filip ; Lundgren, Jens ; Nichols, Garrett ; Pikis, Andreas ; Razonable, Raymund R ; Miller, Veronica ; Griffiths, Paul D. / Definitions of cytomegalovirus infection and disease in transplant patients for use in clinical trials. In: Clinical Infectious Diseases. 2017 ; Vol. 64, No. 1. pp. 87-91.
@article{175191012569452e863dfa62a3011f51,
title = "Definitions of cytomegalovirus infection and disease in transplant patients for use in clinical trials",
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.",
keywords = "Clinical trials, CMV, Organ transplantation, Stem cell transplantation",
author = "Per Ljungman and Michael Boeckh and Hirsch, {Hans H.} and Filip Josephson and Jens Lundgren and Garrett Nichols and Andreas Pikis and Razonable, {Raymund R} and Veronica Miller and Griffiths, {Paul D.}",
year = "2017",
doi = "10.1093/cid/ciw668",
language = "English (US)",
volume = "64",
pages = "87--91",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
number = "1",

}

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 -