CMV PED Study - A Retrospective Observational Study To Understand The Clinical And Economic Burden Associated With Cytomegalovirus Reactivation and Related Health Outcomes In Pediatric Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation In Italy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 230
- 试验地点
- 6
- 主要终点
- Current standard of care in CMV management in terms of PET approach
研究概览
简要总结
This observational retrospective analysis will provide useful information for clinicians and payers, and local guidelines committee members, to improve the understanding of Cytomegalovirus clinical and economic burden and clinical management of pediatric patients undergoing allogeneic Hematopoietic Stem Cells Transplantation in Italy.
详细描述
This is an observational retrospective analysis from the main pediatric centers in Italy (approximately 5 sites). The selected sites will be the most representative of Italy because they perform about 2/3 of all allogeneic HSCT per year.
Index date: date of allogeneic HSCT; retrospective data will be captured in consecutive patients undergoing allogeneic HSCT from January 2018 to June 2020 with maximum 12 months of follow-up for each patient. The data of the patients undergoing allogeneic HSCT after June 2020 will not be captured in order to avoid any possible bias due to off-label access to letermovir.
Medical Records (MR) will be used to describe the risk factors, patient characteristics, treatment patterns, and healthcare resource utilization of subjects who had a CMV infection.
Electronic or paper hospital charts (inpatient), clinical charts (inpatient and outpatient), and outpatient records will all be considered as MR for study purposes.
This is a secondary data collection study from electronic or paper medical chart review, no data from registry will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from birth to less than 18 years of age (at the moment of the allogeneic HSCT);
- •Patients who received allogeneic HSCT between January 2018 and June 2020;
- •Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent & Privacy Form (ICF), if applicable.
排除标准
- •Letermovir use at any time
结局指标
主要结局
Current standard of care in CMV management in terms of PET approach
时间窗: during the first-year post-transplant
It will be described quantitatively by tabulating frequencies and percentages.
Usage of immunosuppression
时间窗: at baseline (day of transplant)
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Current standard of care in CMV management in terms of GCV prophylaxis
时间窗: during the first-year post-transplant
It will be described quantitatively by tabulating frequencies and percentages.
Current standard of care in CMV management in terms of ACV prophylaxis
时间窗: during the first-year post-transplant
It will be described quantitatively by tabulating frequencies and percentages.
Current standard of care in CMV management in terms of other
时间窗: during the first-year post-transplant
It will be described quantitatively by tabulating frequencies and percentages.
Summary of demographic and baseline characteristics
时间窗: at baseline (day of transplant)
Description through frequencies and percentages (for categorical variables) and mean and median values, SD, quartiles, interquartile ranges and extreme values (for continuous variables).
Stem cell source
时间窗: at baseline (day of transplant)
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Conditioning intensity
时间窗: at baseline (day of transplant)
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Underlying condition
时间窗: at baseline (day of transplant)
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
CMV Seroprevalence in the under 18 population undergoing allogeneic HSCT
时间窗: at baseline (day of transplant)
Proportion of patients CMV R+ at transplantation. CMV-seroprevalence and serostatus will be described according to the recipient or donor positivity. Comparisons will be conducted using the Chi-square or Fisher's exact test (for categorical variables), or the t-test or Wilcoxon rank sum test (for continuous variables).
CMV serostatus
时间窗: at baseline (day of transplant)
R+/D-, R+/D+ and R-/D+ combination frequencies. CMV-seroprevalence and serostatus will be described according to the recipient or donor positivity. Comparisons will be conducted using the Chi-square or Fisher's exact test (for categorical variables), or the t-test or Wilcoxon rank sum test (for continuous variables).
Donor type
时间窗: at baseline (day of transplant)
Allogeneic HSCT characteristics
次要结局
- CMV-related complications(at day +100, day +200 and during the first year post allogeneic HCT)
- CMV-related complications(during the first-year post-transplant)
- Rate of clinically significant CMV infection(at day +100, day +200 and during the first year post allogeneic HCT)
- Median time to first CS-CMVi(during the first year after transplantation)
- Rate of viral infections other than CMV(at day +100, day +200 and during the first year post allogeneic HCT)
- Rate of bacterial infections(at day +100, day +200 and during the first year post allogeneic HCT)
- Rate of fungal infections(at day +100, day +200 and during the first year post allogeneic HCT)
- Allogeneic HSCT risk factors(at baseline (day of transplant))
- All-cause mortality rate(at day +100, day +200 and during the first year post allogeneic HCT)
- Number of hospitalizations and length of stay (LOS) after allogeneic HSCT(at day +100, day +200 and during the first year post allogeneic HCT)