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Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

NCT05198570 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-06-04

No results posted yet for this study

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.

Conditions

  • Herpesviridae Infections
  • Herpes Simplex 1
  • Varicella Zoster Virus Infection
  • Transplantation Infection
  • Oncology

Interventions

OTHER

Pharmacokinetic analysis

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

Sponsors & Collaborators

  • IRCCS Burlo Garofolo

    collaborator OTHER

  • University of Pisa

    lead OTHER

Principal Investigators

  • Natalia Maximova, MD · IRCCS Burlo Garofolo

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05198570 on ClinicalTrials.gov