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NCT Number: NCT06916195

Burden of Cytomegalovirus Reactivation in Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplantation

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.

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Key information

Conditions

Cytomegalovirus Infection Cytomegalovirus Infections DNA Virus Infections Hematopoietic Stem Cells Transplantation Herpesviridae Infections Infections Virus Diseases

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Giannina Gaslini, Trapianto di Cellule Staminali Emopoietiche, Dipartimento di Onco-Ematologia Pediatrica, Genova, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. Donor type

    Time frame: at baseline (day of transplant)

    Allogeneic HSCT characteristics

  5. Stem cell source

    Time frame: at baseline (day of transplant)

    Allogeneic Hematopoietic Stem Cells Transplantation characteristics

  6. Conditioning intensity

    Time frame: at baseline (day of transplant)

    Allogeneic Hematopoietic Stem Cells Transplantation characteristics

  7. Underlying condition

    Time frame: at baseline (day of transplant)

    Allogeneic Hematopoietic Stem Cells Transplantation characteristics

  8. Usage of immunosuppression

    Time frame: at baseline (day of transplant)

    Allogeneic Hematopoietic Stem Cells Transplantation characteristics

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Secondary outcomes

  1. Rate of clinically significant CMV infection

    Time frame: at day +100, day +200 and during the first year post allogeneic HCT

    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.

  2. Median time to first CS-CMVi

    Time frame: during the first year after transplantation

    A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.

  3. Rate of viral infections other than CMV

    Time frame: at day +100, day +200 and during the first year post allogeneic HCT

    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.

  4. Rate of bacterial infections

    Time frame: at day +100, day +200 and during the first year post allogeneic HCT

    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.

  5. Rate of fungal infections

    Time frame: at day +100, day +200 and during the first year post allogeneic HCT

    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.

  6. Allogeneic HSCT risk factors

    Time frame: at baseline (day of transplant)

    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.

  7. CMV-related complications

    Time frame: during the first-year post-transplant

    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.

  8. CMV-related complications

    Time frame: at day +100, day +200 and during the first year post allogeneic HCT

    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.

  9. CMV-related complications

    Time frame: during the first-year post-transplant

    Rate of opportunistic infection declared by the investigator "CMV related-complication"

  10. 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

    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.

  11. All-cause mortality rate

    Time frame: at day +100, day +200 and during the first year post allogeneic HCT

    Kaplan-Meier curves will describe the timing of events.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonia Maffucci

CONTACT

[email protected]

+39 03626331

Sponsors and collaborators

Lead sponsor

MSD Italia S.r.l.

Industry

Registry information

Official study 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

Acronym: CMV PED

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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