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
Copyright policy )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
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 .
cytomegalovirus, immuno-guided prophylaxis, lung transplantation, Time Factors, antivíricos, FENÓMENOS Y PROCESOS::fenómenos del sistema inmunitario::inmunidad::inmunidad adaptativa::inmunidad celular, Premedication, humanos, Cytomegalovirus, PHENOMENA AND PROCESSES::Immune System Phenomena::Immunity::Adaptive Immunity::Immunity, Cellular, estudios multicéntricos como asunto, Immunitat cel·lular, Postoperative Complications, infecciones por Citomegalovirus, Estudios multicéntricos como asunto, Multicenter Studies as Topic, Multicenter studies as topic, Treatment outcome, Medicaments antivírics, inmunoterapia, Randomized Controlled Trials as Topic, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::intervenciones quirúrgicas::procedimientos quirúrgicos torácicos::procedimientos quirúrgicos pulmonares::trasplante de pulmón, Cytomegalovirus infections, Immunity, Cellular, Immunity, cellular, resultado del tratamiento, ensayos clínicos controlados aleatorizados como asunto, inmunidad, R, Pulmons - Trasplantament, Combined modality therapy, Combined Modality Therapy, Lung transplantation, Infectious Diseases, Treatment Outcome, premedicación, Cytomegalovirus Infections, INIBIC, Medicine, Equivalence trials as topic, Lung Transplantation, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Surgical Procedures, Operative::Thoracic Surgical Procedures::Pulmonary Surgical Procedures::Lung Transplantation, Infeccions per citomegalovirus, Immuno-guided prophylaxis, CHUAC, ENFERMEDADES::virosis::infecciones por virus ADN::infecciones por Herpesviridae::infecciones por Citomegalovirus, Equivalence Trials as Topic, Antiviral Agents, bocavirus, incidencia, Postoperative complications, factores de tiempo, Randomized controlled trials as topic, Trasplante de pulmón, lung transplantation, Humans, cytomegalovirus, immuno-guided prophylaxis, Terapia combinada, Time factors, DISEASES::Virus Diseases::DNA Virus Infections::Herpesviridae Infections::Cytomegalovirus Infections, Immunity, Estudios de equivalencia como asunto, citomegalovirus, Infecciones por citomegalovirus, tratamiento combinado, Antiviral agents, trasplante de pulmón, Clinical Trials, Phase III as Topic, complicaciones postoperatorias, Citomegalovirus, Clinical trials, phase III as topic, Inmunidad celular
cytomegalovirus, immuno-guided prophylaxis, lung transplantation, Time Factors, antivíricos, FENÓMENOS Y PROCESOS::fenómenos del sistema inmunitario::inmunidad::inmunidad adaptativa::inmunidad celular, Premedication, humanos, Cytomegalovirus, PHENOMENA AND PROCESSES::Immune System Phenomena::Immunity::Adaptive Immunity::Immunity, Cellular, estudios multicéntricos como asunto, Immunitat cel·lular, Postoperative Complications, infecciones por Citomegalovirus, Estudios multicéntricos como asunto, Multicenter Studies as Topic, Multicenter studies as topic, Treatment outcome, Medicaments antivírics, inmunoterapia, Randomized Controlled Trials as Topic, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::intervenciones quirúrgicas::procedimientos quirúrgicos torácicos::procedimientos quirúrgicos pulmonares::trasplante de pulmón, Cytomegalovirus infections, Immunity, Cellular, Immunity, cellular, resultado del tratamiento, ensayos clínicos controlados aleatorizados como asunto, inmunidad, R, Pulmons - Trasplantament, Combined modality therapy, Combined Modality Therapy, Lung transplantation, Infectious Diseases, Treatment Outcome, premedicación, Cytomegalovirus Infections, INIBIC, Medicine, Equivalence trials as topic, Lung Transplantation, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Surgical Procedures, Operative::Thoracic Surgical Procedures::Pulmonary Surgical Procedures::Lung Transplantation, Infeccions per citomegalovirus, Immuno-guided prophylaxis, CHUAC, ENFERMEDADES::virosis::infecciones por virus ADN::infecciones por Herpesviridae::infecciones por Citomegalovirus, Equivalence Trials as Topic, Antiviral Agents, bocavirus, incidencia, Postoperative complications, factores de tiempo, Randomized controlled trials as topic, Trasplante de pulmón, lung transplantation, Humans, cytomegalovirus, immuno-guided prophylaxis, Terapia combinada, Time factors, DISEASES::Virus Diseases::DNA Virus Infections::Herpesviridae Infections::Cytomegalovirus Infections, Immunity, Estudios de equivalencia como asunto, citomegalovirus, Infecciones por citomegalovirus, tratamiento combinado, Antiviral agents, trasplante de pulmón, Clinical Trials, Phase III as Topic, complicaciones postoperatorias, Citomegalovirus, Clinical trials, phase III as topic, Inmunidad celular
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