NCT05198570 Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
| NCT ID | NCT05198570 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pisa |
| Condition | Herpesviridae Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-09-15 |
| Primary Completion | 2025-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * lack of signed informed consent * lack of TDM for ACV * unavailable patient's demographic characteristics