Consensus Definitions of Cytomegalovirus (CMV) Infection and Disease in Transplant Patients Including Resistant and Refractory CMV for Use in Clinical Trials: 2024 Update From the Transplant Associated Virus Infections Forum
Por:
Ljungman P, Chemaly RF, Khawaya F, Alain S, Avery R, Badshah C, Boeckh M, Fournier M, Hodowanec A, Komatsu T, Limaye AP, Manuel O, Natori Y, Navarro D, Pikis A, Razonable RR, Westman G, Miller V, Griffiths PD, Kotton CN
Publicada:
23 jul 2024
Ahead of Print:
1 jul 2024
Resumen:
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 2017. Since then, there have been major developments, including registration of new antiviral agents. Therefore, the Transplant Associated Virus Infections Forum, which consists of scientists, clinicians, regulators, and industry representatives, has produced an updated version of these definitions that incorporates recent knowledge with the aim of supporting clinical research and drug development. This also includes an update regarding the definition of resistant and refractory CMV infections previously published in 2019. As the field evolves, the need for updates of these definitions is clear, and collaborative efforts among clinicians, scientists, regulators, and industry representatives can provide a platform for this work.
The existing definitions of cytomegalovirus (CMV) infection and disease for use in clinical trials have been updated. The update is based on new developments including the introduction of clinically significant CMV infection and developments in diagnosis of CMV disease.
Filiaciones:
Ljungman P:
Department of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska University Hospital Huddinge, Karolinska Comprehensive Cancer Center, Stockholm, Sweden
Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden
Chemaly RF:
Department of Infectious Diseases, Infection Control, and Employee Health, University of Texas MD Anderson Cancer Center, Houston, Texas, USA
Khawaya F:
Department of Infectious Diseases, Infection Control, and Employee Health, University of Texas MD Anderson Cancer Center, Houston, Texas, USA
Alain S:
Laboratoire de Bactériologie-Virologie-Hygiène, French National Reference Center for Herpesviruses, CHU Limoges, Limoges, France
Avery R:
Division of Infectious Diseases, Johns Hopkins, Baltimore, Maryland, USA
Badshah C:
Merck & Co, Inc., Rahway, New Jersey, USA
Boeckh M:
Vaccine and Infectious Disease and Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA
Department of Medicine, University of Washington, Seattle, Washington, USA
Fournier M:
Takeda Pharmaceuticals Inc., Cambridge, Massachusetts, USA
Hodowanec A:
Division of Antivirals, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
Komatsu T:
Division of Antivirals, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
Limaye AP:
Department of Medicine, Division of Allergy & Infectious Diseases, University of Washington, Seattle, Washington, USA
Manuel O:
Infectious Diseases Service and Transplantation Center, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
Natori Y:
Division of Infectious Diseases, Miami Transplant Institute, Jackson Health System, University of Miami Miller School of Medicine, Miami, Florida, USA
Navarro D:
Microbiology Service, Clinic University Hospital, INCLIVA Biomedical Research Institute, Department of Microbiology, School of Medicine, University of Valencia, Valencia, Spain
Centro de Investigación Biomédica en Red Enfermedades Infecciosas, Valencia, Spain
Pikis A:
Division of Antivirals, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
Razonable RR:
Division of Public Health, Infectious Diseases and Occupational Medicine, Department of Medicine, Mayo Clinic, Rochester, Minnesota, USA
William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic, Rochester, Minnesota, USA
Westman G:
Swedish Medical Products Agency, Uppsala, Sweden
Department of Medical Sciences, Section of Infectious Diseases, Uppsala University, Uppsala, Sweden
Miller V:
Forum for Collaborative Research, University of California, Berkeley, California, USA
Griffiths PD:
Institute for Immunity and Transplantation, University College London Medical School, London, United Kingdom
Kotton CN:
Transplant and Immunocompromised Host Infectious Diseases Infectious Diseases Division, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
Green Published, hybrid
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