Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorUniversity of Pisa

About this trial

* 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.

Eligibility criteria

Qualifiers

Patients with Hematological malignancies

HSCT recipients who require ACV prophylaxis or treatment for HSV-VZV infection or

Children undergoing high-intensity antineoplastic chemotherapy who need ACV treatment.

Intravenous or oral ACV dosing

Disqualifiers

lack of signed informed consent

lack of TDM for ACV

unavailable patient's demographic characteristics

Trial design

Treatments tested in this trial

  • Pharmacokinetic analysis

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Pisa

Lead sponsor

IRCCS Burlo Garofolo

Collaborator