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RECRUITING
NCT05198570

Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

Sponsor: University of Pisa

View on ClinicalTrials.gov

Summary

* Herpesvirus infections may be severe in immunocompromised patients, with a high risk of complications and mortality. * Recipients of hematopoietic stem cell transplant (HSCT) or patients receiving high-intensity chemotherapy for hematological malignancies are the most vulnerable individuals. * Although the worldwide prevalence of herpes simplex virus 1 (HSV-1) and varicella-zoster virus (VZV), antiviral prophylaxis in seropositive HSCT recipients has significantly reduced the rate of infection. * Acyclovir (ACV) is the first-choice drug for the prophylaxis or the therapy of that kind of infection. * Since the beginning, ACV has demonstrated to be characterized by a large interpatient variability, especially in children. * Therefore, therapeutic drug monitoring and pharmacokinetic studies may help in optimizing drug in children with malignancies.

Official title: Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy

Key Details

Gender

All

Age Range

6 Months - 18 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2021-09-15

Completion Date

2026-03-31

Last Updated

2025-06-04

Healthy Volunteers

No

Interventions

OTHER

Pharmacokinetic analysis

Population pharmacokinetic analysis of plasma concentrations of aciclovir obtained during routine therapeutic drug monitoring

Locations (1)

IRCCS Burlo Garofolo, Bone Marrow Transplant Unit, Institute for Maternal and Child Health

Trieste, TS, Italy