Clinical Trial

Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

Recruiting
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Record status
This record was last updated June 4, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-01-19; most recent amendment 2025-06-02.
Status change: Active, Not Recruiting → Recruiting 2023-10-05
Trial Details
NCT Number NCT05198570
Lead Sponsor University of Pisa
Collaborators: IRCCS Burlo Garofolo
Conditions Herpesviridae Infections, Herpes Simplex 1, Varicella Zoster Virus Infection, Transplantation Infection, Oncology
Enrollment 200 participants
Start Date 2021-09-15
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-06-04