Burden of Cytomegalovirus Reactivation in Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cytomegalovirus Infection, Hematopoietic Stem Cells Transplantation. Basic parameters: 0 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Primary outcome measures
- Summary of demographic and baseline characteristics [Time frame: at baseline (day of transplant)]
- CMV Seroprevalence in the under 18 population undergoing allogeneic HSCT [Time frame: at baseline (day of transplant)]
- CMV serostatus [Time frame: at baseline (day of transplant)]
- Donor type [Time frame: at baseline (day of transplant)]
- Stem cell source [Time frame: at baseline (day of transplant)]
- Conditioning intensity [Time frame: at baseline (day of transplant)]
- Underlying condition [Time frame: at baseline (day of transplant)]
- Usage of immunosuppression [Time frame: at baseline (day of transplant)]
- Current standard of care in CMV management in terms of PET approach [Time frame: during the first-year post-transplant]
- Current standard of care in CMV management in terms of GCV prophylaxis [Time frame: during the first-year post-transplant]
Secondary outcome measures (11)
- Rate of clinically significant CMV infection [Time frame: at day +100, day +200 and during the first year post allogeneic HCT]
- Median time to first CS-CMVi [Time frame: during the first year after transplantation]
- Rate of viral infections other than CMV [Time frame: at day +100, day +200 and during the first year post allogeneic HCT]
- Rate of bacterial infections [Time frame: at day +100, day +200 and during the first year post allogeneic HCT]
- Rate of fungal infections [Time frame: at day +100, day +200 and during the first year post allogeneic HCT]
- Allogeneic HSCT risk factors [Time frame: at baseline (day of transplant)]
- CMV-related complications [Time frame: during the first-year post-transplant]
- CMV-related complications [Time frame: at day +100, day +200 and during the first year post allogeneic HCT]
- CMV-related complications [Time frame: during the first-year post-transplant]
- Number of hospitalizations and length of stay (LOS) after allogeneic HSCT [Time frame: at day +100, day +200 and during the first year post allogeneic HCT]
- All-cause mortality rate [Time frame: at day +100, day +200 and during the first year post allogeneic HCT]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 5 centers
- IRCCS Istituto Giannina Gaslini, Trapianto di Cellule Staminali Emopoietiche, Dipartimento — Genova
- Ospedale San Gerardo, Clinica Pediatrica — Monza
- Azienda Ospedale-Università di Padova, Clinica di Oncoematologia Pediatrica — Padova
- IRCCS Ospedale Pediatrico Bambino Gesù, Dipartimento di Pediatria Ematologia e Oncologia — Roma
- Ospedale Infantile Regina Margherita, Dipartimento Patologia e Cura del Bambino — Torino
Identifiers
NCT: NCT06916195 · NIS103043