Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy
University of Pisa
200 participants
Sep 15, 2021
OBSERVATIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria3
- lack of signed informed consent
- lack of TDM for ACV
- unavailable patient's demographic characteristics
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Interventions
Population pharmacokinetic analysis of plasma concentrations of aciclovir obtained during routine therapeutic drug monitoring
Locations(1)
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NCT05198570