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Идёт набор NCT05198570

Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pharmacokinetic analysis.
Кому может быть актуально
Состояния в реестре: Herpesviridae Infections, Herpes Simplex 1, Varicella Zoster Virus Infection, Transplantation Infection. Базовые параметры: 6 мес. — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

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

Обзор

* 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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

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

Публикации

  • 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

Идентификаторы

NCT: NCT05198570 · RC_10/20

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗