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.
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. Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF), if applicable.
Study Type
OBSERVATIONAL
Enrollment
230
IRCCS Istituto Giannina Gaslini, Trapianto di Cellule Staminali Emopoietiche, Dipartimento di Onco-Ematologia Pediatrica
Genova, Italy
RECRUITINGOspedale San Gerardo, Clinica Pediatrica
Monza, Italy
RECRUITINGAzienda Ospedale-Università di Padova, Clinica di Oncoematologia Pediatrica
Padova, Italy
Summary of demographic and baseline characteristics
Description through frequencies and percentages (for categorical variables) and mean and median values, SD, quartiles, interquartile ranges and extreme values (for continuous variables).
Time frame: at baseline (day of transplant)
CMV Seroprevalence in the under 18 population undergoing allogeneic HSCT
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).
Time frame: at baseline (day of transplant)
CMV serostatus
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).
Time frame: at baseline (day of transplant)
Donor type
Allogeneic HSCT characteristics
Time frame: at baseline (day of transplant)
Stem cell source
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Time frame: at baseline (day of transplant)
Conditioning intensity
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Time frame: at baseline (day of transplant)
Underlying condition
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
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IRCCS Ospedale Pediatrico Bambino Gesù, Dipartimento di Pediatria Ematologia e Oncologia
Roma, Italy
RECRUITINGOspedale Infantile Regina Margherita, Dipartimento Patologia e Cura del Bambino
Torino, Italy
RECRUITINGTime frame: at baseline (day of transplant)
Usage of immunosuppression
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Time frame: at baseline (day of transplant)
Current standard of care in CMV management in terms of PET approach
It will be described quantitatively by tabulating frequencies and percentages.
Time frame: during the first-year post-transplant
Current standard of care in CMV management in terms of GCV prophylaxis
It will be described quantitatively by tabulating frequencies and percentages.
Time frame: during the first-year post-transplant
Current standard of care in CMV management in terms of ACV prophylaxis
It will be described quantitatively by tabulating frequencies and percentages.
Time frame: during the first-year post-transplant
Current standard of care in CMV management in terms of other
It will be described quantitatively by tabulating frequencies and percentages.
Time frame: during the first-year post-transplant
Rate of clinically significant CMV infection
Incidence rates will be computed by dividing the number of events by the total number of person-years and then multiplying per 100. A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Time frame: at day +100, day +200 and during the first year post allogeneic HCT
Median time to first CS-CMVi
A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Time frame: during the first year after transplantation
Rate of viral infections other than CMV
Incidence rates will be computed by dividing the number of events by the total number of person-years and then multiplying per 100. A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Time frame: at day +100, day +200 and during the first year post allogeneic HCT
Rate of bacterial infections
Incidence rates will be computed by dividing the number of events by the total number of person-years and then multiplying per 100. A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Time frame: at day +100, day +200 and during the first year post allogeneic HCT
Rate of fungal infections
Incidence rates will be computed by dividing the number of events by the total number of person-years and then multiplying per 100. A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Time frame: at day +100, day +200 and during the first year post allogeneic HCT
Allogeneic HSCT risk factors
Underlying condition, donor type, stem cell source, conditioning intensity, immunosuppressive therapies. The relation between complications and risk factors will be analyzed through Cox regression models.
Time frame: at baseline (day of transplant)
CMV-related complications
Proportion of patients with at least one CMV disease, "overall" and by type of disease, and number of diseases per patient. The relation between complications and risk factors will be analyzed through Cox regression models.
Time frame: during the first-year post-transplant
CMV-related complications
Rate of acute and chronic Graft vs Host Disease Incidence rates will be computed by dividing the number of events by the total number of person-years and then multiplying per 100. A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Time frame: at day +100, day +200 and during the first year post allogeneic HCT
CMV-related complications
Rate of opportunistic infection declared by the investigator "CMV related-complication"
Time frame: during the first-year post-transplant
Number of hospitalizations and length of stay (LOS) after allogeneic HSCT
Utilization of several healthcare resources will be described to quantify the economic burden. Data will include frequency of re-hospitalization, exams, diagnostic tests, visits, drugs use and the duration of re-hospitalization. Statistical tests (Chi-square, Fisher's exact, Student's T or Wilcoxon rank-sum) will be applied based on the variable type.
Time frame: at day +100, day +200 and during the first year post allogeneic HCT
All-cause mortality rate
Kaplan-Meier curves will describe the timing of events.
Time frame: at day +100, day +200 and during the first year post allogeneic HCT