Actively Recruiting
Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Led by University of Pisa · Updated on 2025-06-04
200
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
Sponsors
U
University of Pisa
Lead Sponsor
I
IRCCS Burlo Garofolo
Collaborating Sponsor
AI-Summary
What this Trial Is About
* 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
Official Title
Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with hematological malignancies
- Hematopoietic stem cell transplant recipients who require acyclovir prophylaxis or treatment for HSV or VZV infection
- Children undergoing high-intensity antineoplastic chemotherapy needing acyclovir treatment
- Receiving intravenous or oral acyclovir dosing
- Have an active therapeutic drug monitoring protocol for acyclovir
- Informed consent signed by patient's parents
You will not qualify if you...
- Lack of signed informed consent
- Lack of therapeutic drug monitoring for acyclovir
- Unavailable patient's demographic information
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Burlo Garofolo, Bone Marrow Transplant Unit, Institute for Maternal and Child Health
Trieste, TS, Italy, 34137
Actively Recruiting
Research Team
N
Natalia Maximova, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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