Actively Recruiting
CMV PED Study - A Retrospective Observational Study to Understand the Clinical and Economic Burden of Cytomegalovirus Reactivation in Pediatric Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation in Italy
Led by MSD Italia S.r.l. · Updated on 2026-04-06
230
Participants Needed
5
Research Sites
10 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational retrospective study to better understand the clinical and economic impact of Cytomegalovirus (CMV) reactivation in children who have undergone allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Italy. This study aims to provide valuable information to clinicians, payers, and guideline committees to improve management and care for pediatric patients facing this condition. The study involves reviewing medical records from several major pediatric centers in Italy that perform most of the allogeneic HSCT procedures. Data will be collected for patients who received HSCT between January 2018 and June 2020, with a follow-up period of up to 12 months for each patient. Researchers will analyze factors such as patient characteristics, treatment patterns, and use of healthcare resources related to CMV infection. Participants' medical charts, both electronic and paper, from inpatient and outpatient settings will be examined to gather information on baseline demographics, CMV serostatus, donor type, stem cell source, conditioning intensity, and immunosuppression use. The study will also look at CMV management practices during the first year after transplant, infection rates, complications, hospitalizations, and mortality. No new treatments will be given, and participation involves data collection only. The study will end in July 2026.
CONDITIONS
Brief Title
Burden of Cytomegalovirus Reactivation in Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients from birth to less than 18 years of age at the time of 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, if applicable
You will not qualify if you...
- Use of letermovir at any time
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Retrospective data collection from medical records prior to and at the time of transplant
Duration - Up to 12 months following transplantation
Participants are observed retrospectively for clinical and healthcare resource outcomes related to cytomegalovirus reactivation after allogeneic hematopoietic stem cell transplantation.
Data collected from inpatient and outpatient medical records during the first year after transplant
Trial Site Locations
Total: 5 locations
1
IRCCS Istituto Giannina Gaslini, Trapianto di Cellule Staminali Emopoietiche, Dipartimento di Onco-Ematologia Pediatrica
Genova, Italy
Actively Recruiting
2
Ospedale San Gerardo, Clinica Pediatrica
Monza, Italy, 20900
Actively Recruiting
3
Azienda Ospedale-Università di Padova, Clinica di Oncoematologia Pediatrica
Padova, Italy, 35128
Not Yet Recruiting
4
IRCCS Ospedale Pediatrico Bambino Gesù, Dipartimento di Pediatria Ematologia e Oncologia
Roma, Italy, 00165
Actively Recruiting
5
Ospedale Infantile Regina Margherita, Dipartimento Patologia e Cura del Bambino
Torino, Italy, 10126
Actively Recruiting
Research Team
A
Antonia Maffucci
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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