Population Pharmacokinetics of Intravenous Acyclovir in Oncologic Pediatric Patients.
Natalia Maximova, Daniela Nisticò, Giacomo Luci...
https://pubmed.ncbi.nlm.nih.gov/35496277Actively Recruiting
Age: 6Months - 18Years
All Genders
ID05198570
Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy
Led by University of Pisa · Updated on 2025-06-04
200
Participants Needed
1
Research Sites
12 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 can be very serious, especially for children with blood cancers or those who have received a hematopoietic stem cell transplant (HSCT). These infections carry a high risk of complications and death. Although herpes simplex virus 1 (HSV-1) and varicella-zoster virus (VZV) are common worldwide, antiviral medicines like acyclovir have helped reduce infection rates in children who are at risk. This research studies how acyclovir behaves in the body of children receiving it through an intravenous (IV) or oral route for preventing or treating herpes virus infections. The study involves children with blood cancers or those undergoing high-intensity chemotherapy, as well as HSCT recipients. It uses therapeutic drug monitoring to analyze acyclovir levels in the blood during routine care. Participants will receive acyclovir either by IV or orally as part of their regular treatment. Researchers will collect blood samples to track acyclovir levels and study how the drug is processed by the body. The main measurement is the percentage of patients who reach a minimum acyclovir blood concentration after six months of treatment. Data from this study aims to help improve acyclovir dosing in children with cancer. The study is expected to continue until March 2026.
CONDITIONS
Brief Title
Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Who Can Participate
Age: 6Months - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with hematological malignancies
- HSCT recipients who require acyclovir prophylaxis or treatment for HSV or VZV infection
- Children undergoing high-intensity antineoplastic chemotherapy who need acyclovir treatment
- Receiving intravenous or oral acyclovir dosing
- 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 characteristics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - Up to 6 months since the beginning of acyclovir administration
Participants who undergo routine care are observed through population pharmacokinetic analysis of plasma acyclovir concentrations obtained during therapeutic drug monitoring.
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
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Research Team
N
Natalia Maximova, MD
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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