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Recruiting NCT05198570

Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

— Observational Herpesviridae Infections Herpes Simplex 1 Varicella Zoster Virus Infection Transplantation Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pharmacokinetic analysis.
Who it may be relevant to
Registry conditions: Herpesviridae Infections, Herpes Simplex 1, Varicella Zoster Virus Infection, Transplantation Infection. Basic parameters: 6 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

* 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.

Detailed description

Herpesvirus infections may lead to severe disease with a high risk of complications and mortality in hematopoietic stem cell transplant (HSCT) recipients, or in patients receiving high-intensity chemotherapy for hematological malignancies. That risk is mainly associated with the worldwide prevalence of herpes simplex virus 1 (HSV-1) that increases consistently with age. In particular, the majority of adult leukemia patients are HSV seropositive, while allogeneic HSCT recipients had post-transplant HSV reactivation. It is worth noting that in the first post-transplant year, symptomatic varicella-zoster virus (VZV) reactivation has a rate of 13% - 55% in adult recipients. Similar percentages of children receiving HSCT had VZV reactivation, being also possible a disseminated infection in 10% of children. However, thanks to antiviral prophylaxis in seropositive HSCT recipients, the rate of infection has significantly dropped.

Among the drugs most used for treatment and prophylaxis of HSV/VZV infections among children who are HSCT recipients or undergo a high-intensity chemotherapy, acyclovir represents the drug of choice. Although its role in preventing and treating herpes virus infections, the pharmacokinetics of acyclovir is highly variable, especially in patients in intensive care units, in those who have organ dysfunction, or in children. In particular, information about the optimal use of acyclovir in children with malignancies is limited.

Interventions

  • Other Pharmacokinetic analysis
    Population pharmacokinetic analysis of plasma concentrations of aciclovir obtained during routine therapeutic drug monitoring

Primary outcome measures

  • Percentage of patients who achieve an acyclovir minimum plasma concentration of 0.5 mg/L at steady state [Time frame: Six months since the beginning of acyclovir administration]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Italy · 1 center
  • IRCCS Burlo Garofolo, Bone Marrow Transplant Unit, Institute for Maternal and Child Health — Trieste

Publications

  • Maximova N, Nistico D, Luci G, Simeone R, Piscianz E, Segat L, Barbi E, Di Paolo A. Population Pharmacokinetics of Intravenous Acyclovir in Oncologic Pediatric Patients. Front Pharmacol. 2022 Apr 14;13:865871. doi: 10.3389/fphar.2022.865871. eCollection 2022. PMID 35496277

Identifiers

NCT: NCT05198570 · RC_10/20

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗