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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.
Ljungman, Per; Chemaly, Roy F; Khawaya, Fareed; Alain, Sophie; Avery, Robin; Badshah, Cyrus; Boeckh, Michael; Fournier, Martha; Hodowanec, Aimee; Komatsu, Takashi; Limaye, Ajit P; Manuel, Oriol; Natori, Yoichiro; Navarro, David; Pikis, Andreas; Razonable, Raymund R; Westman, Gabriel; Miller, Veronica; Griffiths, Paul D; Kotton, Camille N.
Affiliation
  • Ljungman P; Department of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska University Hospital Huddinge, Karolinska Comprehensive Cancer Center, Stockholm, Sweden.
  • Chemaly RF; Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden.
  • Khawaya F; Department of Infectious Diseases, Infection Control, and Employee Health, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
  • Alain S; Department of Infectious Diseases, Infection Control, and Employee Health, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
  • Avery R; Laboratoire de Bactériologie-Virologie-Hygiène, French National Reference Center for Herpesviruses, CHU Limoges, Limoges, France.
  • Badshah C; Division of Infectious Diseases, Johns Hopkins, Baltimore, Maryland, USA.
  • Boeckh M; Merck & Co, Inc., Rahway, New Jersey, USA.
  • Fournier M; Vaccine and Infectious Disease and Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
  • Hodowanec A; Department of Medicine, University of Washington, Seattle, Washington, USA.
  • Komatsu T; Takeda Pharmaceuticals Inc., Cambridge, Massachusetts, USA.
  • Limaye AP; Division of Antivirals, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Manuel O; Division of Antivirals, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Natori Y; Department of Medicine, Division of Allergy & Infectious Diseases, University of Washington, Seattle, Washington, USA.
  • Navarro D; Infectious Diseases Service and Transplantation Center, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
  • Pikis A; Division of Infectious Diseases, Miami Transplant Institute, Jackson Health System, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Razonable RR; Microbiology Service, Clinic University Hospital, INCLIVA Biomedical Research Institute, Department of Microbiology, School of Medicine, University of Valencia, Valencia, Spain.
  • Westman G; Centro de Investigación Biomédica en Red Enfermedades Infecciosas, Valencia, Spain.
  • Miller V; Division of Antivirals, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Griffiths PD; Division of Public Health, Infectious Diseases and Occupational Medicine, Department of Medicine, Mayo Clinic, Rochester, Minnesota, USA.
  • Kotton CN; William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic, Rochester, Minnesota, USA.
Clin Infect Dis ; 2024 Jul 23.
Article in En | MEDLINE | ID: mdl-39041385
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 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.
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: Clin Infect Dis Year: 2024 Document type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: Clin Infect Dis Year: 2024 Document type: Article