Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Recruiting now
Conditions studied: Herpesviridae Infections, Herpes Simplex 1, Varicella Zoster Virus Infection, Transplantation Infection, Oncology
In brief
* 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.
Key facts
- Study ID
- NCT05198570
- Run by
- University of Pisa
- People needed
- 200
- Starts
- 2021-09-15
- Expected to finish
- 2026-03-31
- Last updated by the study team
- 2025-06-04
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- lack of signed informed consent
- lack of TDM for ACV
- unavailable patient's demographic characteristics
Where it is running
- IRCCS Burlo Garofolo, Bone Marrow Transplant Unit, Institute for Maternal and Child Health — Trieste, TS, Italy (enrolling)
Full record on ClinicalTrials.gov
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