Clinical trial NCT06916195: Burden of Cytomegalovirus Reactivation in Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplantation
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cytomegalovirus Infection
Hematopoietic Stem Cells Transplantation
Lead sponsor: MSD Italia S.r.l.
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 230
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Letermovir use at any time

Primary outcomes:
measure: Summary of demographic and baseline characteristics
timeFrame: at baseline (day of transplant)
measure: CMV Seroprevalence in the under 18 population undergoing allogeneic HSCT
timeFrame: at baseline (day of transplant)
measure: CMV serostatus
timeFrame: at baseline (day of transplant)
measure: Donor type
timeFrame: at baseline (day of transplant)
measure: Stem cell source
timeFrame: at baseline (day of transplant)
measure: Conditioning intensity
timeFrame: at baseline (day of transplant)
measure: Underlying condition
timeFrame: at baseline (day of transplant)
measure: Usage of immunosuppression
timeFrame: at baseline (day of transplant)
measure: Current standard of care in CMV management in terms of PET approach
timeFrame: during the first-year post-transplant
measure: Current standard of care in CMV management in terms of GCV prophylaxis
timeFrame: during the first-year post-transplant
measure: Current standard of care in CMV management in terms of ACV prophylaxis
timeFrame: during the first-year post-transplant
measure: Current standard of care in CMV management in terms of other
timeFrame: during the first-year post-transplant
Secondary outcomes:
measure: Rate of clinically significant CMV infection
timeFrame: at day +100, day +200 and during the first year post allogeneic HCT
measure: Median time to first CS-CMVi
timeFrame: during the first year after transplantation
measure: Rate of viral infections other than CMV
timeFrame: at day +100, day +200 and during the first year post allogeneic HCT
measure: Rate of bacterial infections
timeFrame: at day +100, day +200 and during the first year post allogeneic HCT
measure: Rate of fungal infections
timeFrame: at day +100, day +200 and during the first year post allogeneic HCT
measure: Allogeneic HSCT risk factors
timeFrame: at baseline (day of transplant)
measure: CMV-related complications
timeFrame: during the first-year post-transplant
measure: CMV-related complications
timeFrame: at day +100, day +200 and during the first year post allogeneic HCT
measure: CMV-related complications
timeFrame: during the first-year post-transplant
measure: Number of hospitalizations and length of stay (LOS) after allogeneic HSCT
timeFrame: at day +100, day +200 and during the first year post allogeneic HCT
measure: All-cause mortality rate
timeFrame: at day +100, day +200 and during the first year post allogeneic HCT
Other outcomes:
Locations:
city: Genova
country: Italy
facility: IRCCS Istituto Giannina Gaslini, Trapianto di Cellule Staminali Emopoietiche, Dipartimento di Onco-Ematologia Pediatrica
city: Monza
country: Italy
facility: Ospedale San Gerardo, Clinica Pediatrica
city: Padova
country: Italy
facility: Azienda Ospedale-Università di Padova, Clinica di Oncoematologia Pediatrica
city: Roma
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesù, Dipartimento di Pediatria Ematologia e Oncologia
city: Torino
country: Italy
facility: Ospedale Infantile Regina Margherita, Dipartimento Patologia e Cura del Bambino
Study officials:
References: