CMV reactivation after allogeneic stem cell transplant in children in Italy.
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
Run by MSD Italia S.r.l. · NCT06916195 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 0 Years to 18 Years |
| Sex | All |
| Enrollment | 230 (estimated) |
| Sponsor | MSD Italia S.r.l. Industry-sponsored |
| Locations | 5 sites (Genova and 4 other locations) |
| Status | Recruiting |
| Started | May 9, 2025 |
| Main results expected | April 30, 2026 |
| Study ends | July 15, 2026 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT06916195 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients transplanted after June 2020, adults, or children who received letermovir are unlikely to benefit from the study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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 -
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 -
Azienda Ospedale-Università di Padova, Clinica di Oncoematologia Pediatrica
Padova, Italy Not yet recruiting
Study contacts
- Study coordinator: Antonia Maffucci
- Email: info.studiclinici@opisresearch.com
- Phone: +39 03626331
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.