CMV reactivation after allogeneic stem cell transplant in children in Italy.
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
This analysis looks at how often and how seriously cytomegalovirus (CMV) reactivates in children who had an allogeneic hematopoietic stem cell transplant in Italy between January 2018 and June 2020.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 230 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | MSD Italia S.r.l. Industry-sponsored |
| Locations | 5 sites (Genova and 4 other locations) |
| Trial ID | NCT06916195 on ClinicalTrials.gov |
What this trial studies
This is a retrospective observational chart review of pediatric patients who received allogeneic HSCT at about five major Italian centers, capturing consecutive transplants from January 2018 to June 2020 with up to 12 months of follow-up. Investigators will extract data from inpatient and outpatient electronic or paper medical records to describe patient characteristics, CMV risk factors, treatment patterns, clinical outcomes, and healthcare resource use. Patients who received letermovir at any time are excluded to avoid treatment-related bias. The goal is to quantify the clinical and economic burden of CMV reactivation to inform clinicians, guideline committees, and payers.
Who should consider this trial
Good fit: Children under 18 at the time of allogeneic HSCT performed in Italy between January 2018 and June 2020, with accessible medical records and consent for chart review, are eligible.
Not a fit: Patients transplanted after June 2020, adults, or children who received letermovir are unlikely to benefit from the study's findings.
Why it matters
Potential benefit: Results could help clinicians and health systems reduce CMV complications and better allocate resources for pediatric transplant care.
How similar studies have performed: Retrospective analyses of CMV burden have informed adult transplant practice, but pediatric-specific data are more limited, so this established method addresses a gap in pediatric evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Genova and 4 other locations
- IRCCS Istituto Giannina Gaslini, Trapianto di Cellule Staminali Emopoietiche, Dipartimento di Onco-Ematologia Pediatrica — Genova, Italy (Recruiting)
- Ospedale San Gerardo, Clinica Pediatrica — Monza, Italy (Recruiting)
- Azienda Ospedale-Università di Padova, Clinica di Oncoematologia Pediatrica — Padova, Italy (Not_yet_recruiting)
- IRCCS Ospedale Pediatrico Bambino Gesù, Dipartimento di Pediatria Ematologia e Oncologia — Roma, Italy (Recruiting)
- Ospedale Infantile Regina Margherita, Dipartimento Patologia e Cura del Bambino — Torino, Italy (Recruiting)
Study contacts
- Study coordinator: Antonia Maffucci
- Email: info.studiclinici@opisresearch.com
- Phone: +39 03626331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.