A Prospective, Multicenter Survey of Cytomegalovirus (CMV) and Other Herpesviruses Infections and Diseases in Allogeneic Hematopoietic Stem Cell Transplant (allo-HSCT) Recipients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,310
- 试验地点
- 50
- 主要终点
- Cytomegalovirus infection
研究概览
简要总结
Prospective observational study of epidemiological surveillance, multicenter, non-profit, spontaneous, Italian with objective to describe the incidence of CMV infections and diseases in adult and pediatric patients undergoing allo-HSCT during the first 6 months from transplant. This study will evaluate approximately 1500 subjects (with competitive enrolment) from GITMO investigational centers.
详细描述
This is a prospective observational study of epidemiological surveillance, multicenter, non-profit, spontaneous, italian on patients submitted to allogeneic haematopoietic stem cell transplantation organized under the auspices of the Gruppo Italiano Trapianti di Midollo Osseo that involves the principal Centres active in transplantation of any kind of hematopoietic stem cells in Italy.
Allogeneic haematopoietic stem cell transplantation patients continue to be one of the highest risk categories for developing viral infections. Cytomegalovirus infection is the leading viral cause of morbidity and mortality and HHV6 and EBV are other major causes of complications in transplant. The risk of these infections is directly related to the type of transplant.
A better and continuous monitoring of Cytomegalovirus and other herpesviruses complication in this setting would contribute to a better knowledge of the evolving epidemiology and would lead to a better use of diagnostic strategies and of preventive and therapeutic measures.
This study is aimed to identify epidemiological characteristics of allogeneic haematopoietic stem cell transplantation patients developing cytomegalovirus and other herpesviruses infections, risk factors, diagnostic peculiarities and factors that may guide to pre-emptive therapy versus prophylaxis strategies.
Virological monitoring and health care resources utilization in Allogeneic haematopoietic stem cell transplantation recipients according to the different risk of viral infection will be also assessed. This prospective analysis will provide useful information for local clinicians to define tailored antiviral strategies in line with the change of transplantation procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prospective observational study of epidemiological surveillance, multicenter, non-profit, spontaneous, Italian with objective to describe the incidence of CMV infections and diseases in adult and pediatric patients undergoing allo-HSCT during the first 6 months from transplant. This study will evaluate approximately 1500 subjects, with competitive enrolment from GITMO investigational centers.
排除标准
- •Absence of consent Written information
结局指标
主要结局
Cytomegalovirus infection
时间窗: 6 months from transplant
incidence of Cytomegalovirus after allogeneic haematopoietic stem cell transplantation
Cytomegalovirus disease
时间窗: 6 months from transplant
incidence of Cytomegalovirus after allogeneic haematopoietic stem cell transplantation
Herpesvirus human 6 disease
时间窗: 6 months from transplant
incidence of human 6 disease after allogeneic haematopoietic stem cell transplantation
Virus Epstein-Barr infection
时间窗: 6 months from transplant
incidence of Virus Epstein-Barr infections after allogeneic haematopoietic stem cell transplantation
Virus Epstein-Barr disease
时间窗: 6 months from transplant
incidence of Virus Epstein-Barr disease after allogeneic haematopoietic stem cell transplantation
Herpesvirus human 6 infection
时间窗: 6 months from transplant
incidence of human 6 infection after allogeneic haematopoietic stem cell transplantation
次要结局
- Overall Survival (OS)(These outcome measures will be assessed at 1 year from transplant)
- Disease Free Survival (DFS)(These outcome measures will be assessed at 1 year from transplant)
- Transplant Related Mortality (TRM)(These outcome measures will be assessed at 1 year from transplant)
- chronic graft-versus-host disease(These outcome measures will be assessed at 1 year from transplant)
- Relapse risk (RR)(These outcome measures will be assessed at 1 year from transplant)
- Acute Graft-versus-Host Disease(These outcome measures will be assessed at 100 days from transplant)
