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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | at baseline (day of transplant) |
| Donor type | Allogeneic HSCT characteristics | at baseline (day of transplant) |
| Stem cell source | Allogeneic Hematopoietic Stem Cells Transplantation characteristics | at baseline (day of transplant) |
| Conditioning intensity | Allogeneic Hematopoietic Stem Cells Transplantation characteristics | at baseline (day of transplant) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at day +100, day +200 and during the first year post allogeneic HCT |
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Inclusion Criteria:
Exclusion Criteria:
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About 230 patients from birth to less than 18 years of age allogeneic HSCT recipients at risk of developing CMV infection and/or disease who underwent allogeneic HSCT between January 2018 and June 2020 in the participating hospitals will be enrolled in the study. The selected hospitals will be the main ones in Italy based on the number of transplants performed every year and also considering the geographical distribution.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonia Maffucci | Contact | +39 03626331 | info.studiclinici@opisresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Giannina Gaslini, Trapianto di Cellule Staminali Emopoietiche, Dipartimento di Onco-Ematologia Pediatrica | Recruiting | Genova | Italy |
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Underlying condition | Allogeneic Hematopoietic Stem Cells Transplantation characteristics | at baseline (day of transplant) |
| Usage of immunosuppression | Allogeneic Hematopoietic Stem Cells Transplantation characteristics | 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. | 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. | 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. | 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. | during the first-year post-transplant |
| Median time to first CS-CMVi |
A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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" | 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. | 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. | at day +100, day +200 and during the first year post allogeneic HCT |
| Ospedale San Gerardo, Clinica Pediatrica | Recruiting | Monza | 20900 | Italy |
| Azienda Ospedale-Università di Padova, Clinica di Oncoematologia Pediatrica | Not yet recruiting | Padova | 35128 | Italy |
| IRCCS Ospedale Pediatrico Bambino Gesù, Dipartimento di Pediatria Ematologia e Oncologia | Recruiting | Roma | 00165 | Italy |
| Ospedale Infantile Regina Margherita, Dipartimento Patologia e Cura del Bambino | Recruiting | Torino | 10126 | Italy |