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

NCT06916195 | Recruiting

• 1 other identifier: NIS103043
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 5

Brief 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 Transplantation in Italy.

Conditions

Cytomegalovirus Infection; Hematopoietic Stem Cells Transplantation

Outcome Measures

Primary Outcomes (12)

• 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).

  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).

  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).

  at baseline (day of transplant)

• Donor type

  Allogeneic HSCT characteristics

  at baseline (day of transplant)

• Stem cell source

  Allogeneic Hematopoietic Stem Cells Transplantation characteristics

  at baseline (day of transplant)

• Conditioning intensity

  Allogeneic Hematopoietic Stem Cells Transplantation characteristics

  at baseline (day of transplant)

• Underlying condition

  Allogeneic Hematopoietic Stem Cells Transplantation characteristics

  at baseline (day of transplant)

• Usage of immunosuppression

  Allogeneic Hematopoietic Stem Cells Transplantation characteristics

  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.

  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.

  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.

  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.

  during the first-year post-transplant

Secondary Outcomes (11)

• Rate of clinically significant CMV infection

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

• Median time to first CS-CMVi

  during the first year after transplantation

• Rate of viral infections other than CMV

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

• Rate of bacterial infections

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

• Rate of fungal infections

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

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Letermovir use at any time

Sponsors & Collaborators

• MSD Italia S.r.l.: lead

Study Sites (5)

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

Genova, Italy

RECRUITING

Ospedale San Gerardo, Clinica Pediatrica

Monza, 20900, Italy

RECRUITING

Azienda Ospedale-Università di Padova, Clinica di Oncoematologia Pediatrica

Padua, 35128, Italy

NOT YET RECRUITING

IRCCS Ospedale Pediatrico Bambino Gesù, Dipartimento di Pediatria Ematologia e Oncologia

Roma, 00165, Italy

NOT YET RECRUITING

Ospedale Infantile Regina Margherita, Dipartimento Patologia e Cura del Bambino

Torino, 10126, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Antonia Maffucci

CONTACT

+39 03626331; info.studiclinici@opisresearch.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: May 9, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-05

Locations

IT (5)