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Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

RECRUITINGSponsored by University of Pisa
Actively Recruiting
SponsorUniversity of Pisa
Started2021-09-15
Est. completion2025-12-31
Eligibility
Age6 Months – 18 Years
Healthy vol.Accepted

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.

Eligibility

Age: 6 Months – 18 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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
* Active/available a therapeutic drug monitoring (TDM) protocol for ACV
* Informed consent signed by patient's parents

Exclusion Criteria:

* lack of signed informed consent
* lack of TDM for ACV
* unavailable patient's demographic characteristics

Conditions6

CancerHerpes Simplex 1Herpesviridae InfectionsOncologyTransplantation InfectionVaricella Zoster Virus Infection

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