About this trial
* 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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
lack of signed informed consent
lack of TDM for ACV
unavailable patient's demographic characteristics
Trial population
Patients aged 0-18 years, affected by hematological malignancies, undergoing ACV prophylaxis or treatment for HSV-VZV infection routinely during allogeneic HSCT or ACV treatment during high-intensity chemotherapy, for who a therapeutic drug monitoring (TDM) protocol is available. Patients receive ACV as a standard 1-h intravenous infusion or through the oral administration of valaciclovir
Trial design
Case-only
Retrospective
Treatments tested in this trial
Pharmacokinetic analysis
Other interventionPopulation pharmacokinetic analysis of plasma concentrations of aciclovir obtained during routine therapeutic drug monitoring
Treatment groups
Trial outcomes
Primary outcomes
Percentage of patients who achieve an acyclovir minimum plasma concentration of 0.5 mg/L at steady state
Percentage of patients who achieve an acyclovir minimum plasma concentration at steady state ≥0.5 mg/L, considered as an effective plasma concentration
Sponsors and contacts
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University of Pisa
Lead sponsor
IRCCS Burlo Garofolo
Collaborator