Efficacy and safety of the combination of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease in lung transplant recipients (CYTOCOR STUDY) : An open-label, randomised, non-inferiority clinical trial
Páez-Vega, Aurora (Spanish Network for Research in Infectious Diseases)
Cantisan, Sara (Hospital Universitario Reina Sofía (Còrdova, Espanya))
Vaquero, José Manuel (Hospital Universitario Reina Sofía (Còrdova, Espanya))
Vidal, Elisa (Hospital Universitario Reina Sofía (Còrdova, Espanya))
Luque-Pineda, Antonio (Instituto Maimónides de Investigación Biomédica de Córdoba)
Lobo-Acosta, María Ángeles (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Pérez, Ana Belén (Hospital Universitario Reina Sofía (Còrdova, Espanya))
Alonso-Moralejo, Rodrigo (Hospital Universitario 12 de Octubre (Madrid))
Iturbe, David (Instituto de Investigación Sanitaria Valdecilla (Santander, Cantàbria))
Monforte, Víctor (Hospital Universitari Vall d'Hebron)
Otero-González, Isabel (Instituto de Investigación Biomédica de A Coruña)
Pastor, Amparo (Hospital Universitari i Politècnic La Fe (València))
Ussetti, Piedad (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Torre-Cisneros, Julian (Hospital Universitario Reina Sofía (Còrdova, Espanya))
Universitat Autònoma de Barcelona

Fecha:	2019
Resumen:	Introduction Prolonged use of antivirals to prevent the development of cytomegalovirus (CMV) disease in lung transplant patients has been shown to have significant side effects, for which alternatives are being sought to reduce their use. The monitoring of cell immunity against CMV could be an alternative as it has shown to be useful in identifying transplant patients at low risk of infection, who could benefit from shorter prophylaxis. The aim of the CYTOCOR study is to demonstrate that the combination of a reduced prophylaxis strategy with subsequent CMV-specific immunological monitoring would allow CMV infection to be controlled in lung transplant patients as effectively as the usual strategy (prophylaxis followed by pre-emptive therapy), while reducing the side effects of antivirals due to the shorter duration of prophylaxis. Methods and analysis Phase III randomised, open, multicentre, parallel, non-inferiority clinical trial to study the efficacy and safety of the combination of a prophylaxis strategy up to month +3 post-transplant followed by immuno-guided prophylaxis using the QuantiFERON-CMV technique up to month +12 post-transplant to prevent CMV disease in CMV-seropositive lung transplant recipients. This strategy will be compared with a combination of a usual prophylaxis strategy up to month +6 post-transplant followed by pre-emptive therapy up to month +12. To study the incidence of CMV disease, patients will be followed up to 18 months post-transplantation. A total of 150 patients are expected to be recruited for the study. Ethics and public dissemination The clinical trial has been approved by the Research Ethics Committees and authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS). If the hypothesis of this clinical trial is verified, the dissemination of the results could change clinical practice by increasing knowledge about the safety and efficacy of discontinuing valganciclovir prophylaxis in lung transplant recipients. Trial registration number NCT03699254.
Ayudas:	Instituto de Salud Carlos III PT13/0002/0010 Instituto de Salud Carlos III PT17-0017/0012 Instituto de Salud Carlos III PT17/0017/0032
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Publicado en:	BMJ open, Vol. 9 Núm. 8 (january 2019) , p. e030648, ISSN 2044-6055

DOI: 10.1136/bmjopen-2019-030648
PMID: 31420397

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