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Clin Infect Dis. 2017 Jan 1;64(1):87-91. Epub 2016 Sep 28.

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

Author information

1
Departments of Allogeneic Stem Cell Transplantations and Hematology, Karolinska University Hospital, Solna.
2
Division of Hematology, Department of Medicine, Huddinge, Karolinska Institutet, Stockholm.
3
Vaccine and Infectious Disease and Clinical Research Division, Fred Hutchinson Cancer Research Center.
4
Department of Medicine, University of Washington, Seattle.
5
Department of Biomedicine, University of Basel, Switzerland.
6
Swedish Medical Products Agency, Uppsala, Sweden.
7
Centre for Health and Infectious Disease Research (CHIP), Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.
8
Chimerix, Inc, Durham, North Carolina.
9
Division of Antiviral Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
10
Division of Infectious Diseases, Department of Medicine, William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic, Rochester, Minnesota.
11
Forum for Collaborative HIV Research, University of California, Berkeley.
12
Institute for Immunity and Transplantation, University College London Medical School, United Kingdom.

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.

KEYWORDS:

CMV; clinical trials; organ transplantation; stem cell transplantation

PMID:
27682069
DOI:
10.1093/cid/ciw668
[Indexed for MEDLINE]

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