Cytomegalovirus InfectionCMV PEDNCT06916195
Burden of Cytomegalovirus Reactivation in Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplantation
An observational study of Cytomegalovirus Infection and Hematopoietic Stem Cells Transplantation, run by MSD Italia S.r.l. at 5 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Cytomegalovirus Infection, Hematopoietic Stem Cells Transplantation
- How many people
- 230 participants
- Where
- 5 sitesItaly
- Study dates
- 9 May 2025to 15 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Letermovir use at any time
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
IRCCS Istituto Giannina Gaslini, Trapianto di Cellule Staminali Emopoietiche, Dipartimento di Onco-Ematologia Pediatrica
Genova
- Recruiting
Ospedale San Gerardo, Clinica Pediatrica
Monza, 20900
- Not yet recruiting
Azienda Ospedale-Università di Padova, Clinica di Oncoematologia Pediatrica
Padova, 35128
- Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù, Dipartimento di Pediatria Ematologia e Oncologia
Roma, 00165
- Recruiting
Ospedale Infantile Regina Margherita, Dipartimento Patologia e Cura del Bambino
Torino, 10126
About this study
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
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.
Read the 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.
- Medical subject headings
- Cytomegalovirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of demographic and baseline characteristics
Description through frequencies and percentages (for categorical variables) and mean and median values, SD, quartiles, interquartile ranges and extreme values (for continuous variables).
Measured: at baseline (day of transplant)
CMV Seroprevalence in the under 18 population undergoing allogeneic HSCT
Proportion of patients CMV R+ at transplantation. CMV-seroprevalence and serostatus will be described according to the recipient or donor positivity. Comparisons will be conducted using the Chi-square or Fisher's exact test (for categorical variables), or the t-test or Wilcoxon rank sum test (for continuous variables).
Measured: at baseline (day of transplant)
CMV serostatus
R+/D-, R+/D+ and R-/D+ combination frequencies. CMV-seroprevalence and serostatus will be described according to the recipient or donor positivity. Comparisons will be conducted using the Chi-square or Fisher's exact test (for categorical variables), or the t-test or Wilcoxon rank sum test (for continuous variables).
Measured: at baseline (day of transplant)
Donor type
Allogeneic HSCT characteristics
Measured: at baseline (day of transplant)
Stem cell source
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Measured: at baseline (day of transplant)
Conditioning intensity
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Measured: at baseline (day of transplant)
Underlying condition
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Measured: at baseline (day of transplant)
Usage of immunosuppression
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Measured: at baseline (day of transplant)
Current standard of care in CMV management in terms of PET approach
It will be described quantitatively by tabulating frequencies and percentages.
Measured: during the first-year post-transplant
Current standard of care in CMV management in terms of GCV prophylaxis
It will be described quantitatively by tabulating frequencies and percentages.
Measured: during the first-year post-transplant
Current standard of care in CMV management in terms of ACV prophylaxis
It will be described quantitatively by tabulating frequencies and percentages.
Measured: during the first-year post-transplant
Current standard of care in CMV management in terms of other
It will be described quantitatively by tabulating frequencies and percentages.
Measured: during the first-year post-transplant
Secondary outcomes (11)
Rate of clinically significant CMV infection
Incidence rates will be computed by dividing the number of events by the total number of person-years and then multiplying per 100. A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Measured: at day +100, day +200 and during the first year post allogeneic HCT
Median time to first CS-CMVi
A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Measured: during the first year after transplantation
Rate of viral infections other than CMV
Incidence rates will be computed by dividing the number of events by the total number of person-years and then multiplying per 100. A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Measured: at day +100, day +200 and during the first year post allogeneic HCT
Rate of bacterial infections
Incidence rates will be computed by dividing the number of events by the total number of person-years and then multiplying per 100. A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Measured: at day +100, day +200 and during the first year post allogeneic HCT
Rate of fungal infections
Incidence rates will be computed by dividing the number of events by the total number of person-years and then multiplying per 100. A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Measured: at day +100, day +200 and during the first year post allogeneic HCT
Allogeneic HSCT risk factors
Underlying condition, donor type, stem cell source, conditioning intensity, immunosuppressive therapies.
The relation between complications and risk factors will be analyzed through Cox regression models.
Measured: at baseline (day of transplant)
CMV-related complications
Proportion of patients with at least one CMV disease, "overall" and by type of disease, and number of diseases per patient.
The relation between complications and risk factors will be analyzed through Cox regression models.
Measured: during the first-year post-transplant
CMV-related complications
Rate of acute and chronic Graft vs Host Disease Incidence rates will be computed by dividing the number of events by the total number of person-years and then multiplying per 100. A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Measured: at day +100, day +200 and during the first year post allogeneic HCT
CMV-related complications
Rate of opportunistic infection declared by the investigator "CMV related-complication"
Measured: during the first-year post-transplant
Number of hospitalizations and length of stay (LOS) after allogeneic HSCT
Utilization of several healthcare resources will be described to quantify the economic burden. Data will include frequency of re-hospitalization, exams, diagnostic tests, visits, drugs use and the duration of re-hospitalization. Statistical tests (Chi-square, Fisher's exact, Student's T or Wilcoxon rank-sum) will be applied based on the variable type.
Measured: at day +100, day +200 and during the first year post allogeneic HCT
All-cause mortality rate
Kaplan-Meier curves will describe the timing of events.
Measured: at day +100, day +200 and during the first year post allogeneic HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start9 May 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MSD Italia S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916195
- Sponsor's protocol ID
- NIS103043
- Acronym
- CMV PED
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06916195
- Acronym / sponsor ID
- CMV PED / NIS103043
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- MSD Italia S.r.l.Industry (pharma, biotech, devices)
- Study start
- 9 May 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Letermovir use at any time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Summary of demographic and baseline characteristics
Time frame: at baseline (day of transplant)
Description through frequencies and percentages (for categorical variables) and mean and median values, SD, quartiles, interquartile ranges and extreme values (for continuous variables).
CMV Seroprevalence in the under 18 population undergoing allogeneic HSCT
Time frame: at baseline (day of transplant)
Proportion of patients CMV R+ at transplantation. CMV-seroprevalence and serostatus will be described according to the recipient or donor positivity. Comparisons will be conducted using the Chi-square or Fisher's exact test (for categorical variables), or the t-test or Wilcoxon rank sum test (for continuous variables).
CMV serostatus
Time frame: at baseline (day of transplant)
R+/D-, R+/D+ and R-/D+ combination frequencies. CMV-seroprevalence and serostatus will be described according to the recipient or donor positivity. Comparisons will be conducted using the Chi-square or Fisher's exact test (for categorical variables), or the t-test or Wilcoxon rank sum test (for continuous variables).
Donor type
Time frame: at baseline (day of transplant)
Allogeneic HSCT characteristics
Stem cell source
Time frame: at baseline (day of transplant)
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Conditioning intensity
Time frame: at baseline (day of transplant)
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Underlying condition
Time frame: at baseline (day of transplant)
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Usage of immunosuppression
Time frame: at baseline (day of transplant)
Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Current standard of care in CMV management in terms of PET approach
Time frame: during the first-year post-transplant
It will be described quantitatively by tabulating frequencies and percentages.
Current standard of care in CMV management in terms of GCV prophylaxis
Time frame: during the first-year post-transplant
It will be described quantitatively by tabulating frequencies and percentages.
Current standard of care in CMV management in terms of ACV prophylaxis
Time frame: during the first-year post-transplant
It will be described quantitatively by tabulating frequencies and percentages.
Current standard of care in CMV management in terms of other
Time frame: during the first-year post-transplant
It will be described quantitatively by tabulating frequencies and percentages.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infection and Hematopoietic Stem Cells Transplantation, run by MSD Italia S.r.l. at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonia Maffucci (+39 03626331, info.studiclinici@opisresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary of demographic and baseline characteristics (time frame: at baseline (day of transplant)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.