RecruitingNCT05198570

Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

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


Sponsor

University of Pisa

Enrollment

200 participants

Start Date

Sep 15, 2021

Study Type

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

Min Age: 6 MonthsMax Age: 18 Years

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

OTHERPharmacokinetic 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

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NCT05198570


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